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emblem™ s-icd - pulse generator user`s manual

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1. Pacemaker sensing failure lead dislodgment or failure to capture could result in the sensing of two asynchronous sets of signals by the S ICD System causing the rate measurement to be faster and may result in delivery of unnecessary shock therapy Conduction delay may cause the device to oversense the evoked QRS and T wave resulting in unnecessary shock therapy Unipolar pacing and impedance based features can interact with the S ICD This includes bipolar pacemakers that revert or reset to the unipolar pacing mode Refer to the manufacturer s pacemaker manual for considerations when configuring a bipolar pacemaker for compatibility with an S ICD Prior to implantation follow the patient screening tool procedure to assure that the patient s paced S ECG signal passes the criteria The following test procedure aids in determining S ICD System and pacemaker interaction after implantation Warning Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death Note f implanting a pacemaker with an existing S ICD System program the S ICD System to Therapy Off during the implantation and initial testing of the pacemaker During the testing procedure program the pacemaker output to maximum and asynchronously pace in the pacing mode to which the pacemaker w
2. Elective Replacement Indicator ERI When the ERI is detected the device will provide therapy for at least three months if no more than six maximum energy charges shocks occur The patient should be scheduled for replacement of the device End of Life EOL When the EOL indicator is detected the device should be replaced immediately Therapy may not be available when EOL is declared 48 Storing and Analyzing Data The device stores S ECGs for up to 25 treated and 20 untreated tachyarrhythmia episodes An episode is only stored if it progresses to the point where charging is initiated The number of treated episodes untreated episodes and the therapy shocks delivered since the last follow up procedure and initial implant are recorded and stored Through wireless communication with the programmer the stored data is retrieved for analysis and report printouts Note Episode data associated with programmer commanded rescue shocks manual shocks induction testing or episodes that occur while communicating with the programmer are not stored by the pulse generator Episode data associated with induction testing commanded by the programmer using the Hold to Induce button is captured by the programmer and is available as a captured S ECG see the EMBLEM S ICD Programmer User s Manual for more details Note SVT episodes with heart rates lower than or within the Conditional Shock zone are not stored Treated Episodes Up to 128 seconds of
3. Note Special circumstances may present in which the physician elects to proceed with the implantation of the 5 ICD System despite failing the screening process In this case careful attention should be applied to the device setup process of the S ICD System as the risk of poor sensing and or inappropriate shock is increased Operation General The S ICD System is designed for ease of use and simplicity of patient management The arrhythmia detection system employs up to two rate zones and the device has a single automatic response to a detected ventricular tachyarrhythmia a nonprogrammable maximum energy biphasic shock of 80 J The device has a number of automatic functions designed to reduce the amount of time required for implantation initial programming and patient follow up Modes of Operation The device has three modes of operation Shelf Therapy On Therapy Off Shelf Mode The Shelf mode is a low power consumption state intended for storage only When communication is initiated between the device and the programmer a full energy capacitor reformation is performed and the device is prepared for setup Once the device is taken out of Shelf mode it cannot be reprogrammed back into Shelf mode Therapy On Mode The Therapy On mode is the primary operating mode of the device allowing automatic detection of and response to ventricular tachyarrhythmias All device features are active Note The device must be program
4. S ICD pulse generator the device is a component of the Boston Scientific S ICD System which is prescribed for patients when cardiac arrhythmia management is warranted The pulse generator accepts one EMBLEM S ICD subcutaneous electrode with an SQ 1 S ICD connector The EMBLEM S ICD pulse generator is also compatible with the Cameron Health Model 3010 Q TRAK subcutaneous electrode The pulse generator and subcutaneous electrode constitute the implantable portion of the S ICD System The pulse generator can be used only with the EMBLEM S ICD programmer Model 3200 and Model 3203 telemetry wand Related Information For additional information about other components of the S ICD System refer to the following EMBLEM S ICD Subcutaneous Electrode User s Manual EMBLEM S ICD Subcutaneous Electrode Insertion Tool User s Manual EMBLEM S ICD Programmer User s Manual Intended Audience This literature is intended for use by professionals trained or experienced in device implant and or follow up procedures Indications for Use The S ICD System is intended to provide defibrillation therapy for the treatment of life threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia incessant ventricular tachycardia or spontaneous frequently recurring ventricular tachycardia that is reliably terminated with anti tachycardia pacing Contraindications Unipolar pacing and impedance based features are contra
5. Magnet application does not affect wireless communication between the device and the programmer 54 Bidirectional Torque Wrench A torque wrench model 6628 is included in the sterile tray with the pulse generator and is designed for tightening and loosening 2 56 setscrews captured setscrews and setscrews on this and other Boston Scientific pulse generators and lead accessories that have setscrews that spin freely when fully retracted these setscrews typically have white seal plugs This torque wrench is bidirectional and is preset to apply adequate torque to the setscrew and will ratchet when the setscrew is secure The ratchet release mechanism prevents overtightening that could result in device damage To facilitate the loosening of tight extended setscrews this wrench applies more torque in the counterclockwise direction than in the clockwise direction Note As an additional safeguard the tip of the torque wrench is designed to break off if used to overtighten beyond preset torque levels If this occurs the broken tip must be extracted from the setscrew using forceps This torque wrench may also be used for loosening setscrews on other Boston Scientific pulse generators and lead accessories that have setscrews that tighten against a stop when fully retracted these setscrews typically have clear seal plugs However when retracting these setscrews stop turning the torque wrench when the setscrew has come in contact with the stop T
6. Thickness 0 5 in 1 3 cm Content Ferrous alloys coated with epoxy Field Strength A gauss minimum when measured at a distance of 1 5 in 3 8 cm rom magnet surface Note Specifications are also applicable to the Cameron Health magnet Model 4520 Definitions of Package Label Symbols Table 24 Packaging Symbols EMBLEM S ICD Pulse Generator Symbol Description Symbol Description ts using ethylene m i Date of manufacture h Dangerous voltage Use by SN Serial number X Temperature limitation Consult instructions for Open here use 81 Description Do not reuse Do not resterilize Literature enclosed Uncoated device Pulse generator Torque wrench 82 Description Manufacturer Do not use if package is damaged Package contents Lot number SQ 1 S ICD connector non standard Reference number S ICD System and Pacemaker Interaction Warning Using multiple pulse generators could cause pulse generator interaction resulting in patient injury or a lack of therapy delivery Test each system individually and in combination to help prevent undesirable interactions Interaction between the S ICD System and a temporary or permanent pacemaker is possible and can interfere with the identification of tachyarrhythmias in several ways Ifthe pacing pulse is detected the S ICD System may not adjust sensitivity appropriately fail to sense a tachyarrhythmia episode and or not deliver therapy
7. at 50 Hz Induction continues until the Hold To Induce button is released up to a maximum of 10 seconds per attempt Note f necessary the induction can be terminated by disconnecting the wand from the programmer Arrhythmia detection and the Live S ECG are suspended during AC induction Once the Hold to Induce button is released the programmer displays the patient s rhythm Upon detection and confirmation of an induced arrhythmia the S ICD System automatically delivers a shock at the programmed energy output and polarity Note Whenever the programmer is in active communication with an S ICD pulse generator charging of the pulse generator in preparation for delivering a shock whether commanded or in response to a detected arrhythmia is indicated by an audible notification The notification continues until the shock is delivered or aborted Ifthe shock fails to convert the arrhythmia re detection occurs and subsequent shocks are delivered at the pulse generator s maximum energy output 80 J Note The EMBLEM S ICD pulse generator can deliver a maximum of five shocks per episode At any time an 80 J rescue shock can be delivered by pressing the Rescue Shock button Note Following the release of the Hold To Induce button evaluate the sensing markers during the induced rhythm The S ICD System uses a lengthened rhythm detection period Consistent tachy T markers indicate that tachyarrhythmia detection is occurrin
8. such as a muscle artifact or some other extraneous signal Events are also marked as suspect if they appear to derive from double or triple detections of single cardiac events The device is designed to identify and correct multiple detections of wide QRS complexes and or erroneous detections of a T wave Decision Phase The Decision Phase examines all certified events and continuously calculates a running four R to R interval average 4 RR average The 4 RR average is used throughout the analysis as an indicator of the heart rate Therapy Zones The device allows the selection of rate thresholds that define a Shock Zone and an optional Conditional Shock Zone In the Shock Zone rate is the only criterion used to determine if a rhythm will be treated with a shock The Conditional Shock Zone has additional discriminators used to determine if a shock is warranted to treat an arrhythmia The Shock Zone is programmable from 170 250 bpm in increments of 10 bpm The Conditional Shock Zone must be lower than the Shock Zone with a range of 170 240 bpm in increments of 10 bpm Note To ensure proper detection of VF program the Shock Zone or Conditional Shock Zone to 200 bpm or less Note The IDE Study demonstrated a significant reduction in inappropriate therapy with the activation of the Conditional Shock Zone prior to hospital discharge see S ICD System Clinical Investigation page 15 Graphically the use of a Shock Zone and Conditional Sh
9. 200 7 Weight kg Mean SD Median Range 90 5 25 2 86 6 42 6 230 9 BMI Mean SD Median Range 29 7 7 2 29 0 15 2 69 0 20 Table 3 Baseline Characteristics Attribute Statistic Category Creatinine Mean SD Median 1 1 0 4 1 0 mg dL Range 0 3 3 7 Ejection Fraction Mean SD Median 36 1 15 9 31 0 Range 10 0 82 0 n 299 No Physical Limitations 68 21 2 NYHA Il Slight Physical Limitations 146 45 5 Classification ahaa DEE EEE at Enrollment I Marked Physical limitations f f sel n IV Total Physical Limitations 1 0 3 Unknown Not Assessed 51 15 9 Atrial Fibrillation 49 15 3 COPD 27 8 4 Co morbidities KARPE oases History Cancer 31 9 7 n PAREA Congestive Heart Failure 197 61 4 90 28 0 Diabetes Attribute Co morbidities History n Statistic Category Hypertension Myocardial Infarction Stroke Valve Disease 18 5 6 187 58 3 133 41 4 42 13 1 Cardiac Surgical History n Ablation CABG Defibrillator Pacemaker Percutaneous Revascularization Valve Surgery 4 1 2 16 5 0 48 15 0 43 13 4 92 28 7 18 5 6 21 22 Table 4 Indications According to ACC AHA HRS Guidelines sustained VT or VF induced at electrophysiological study N 321 Indication Details Patients n Left ventricular ejection fract
10. It is recommended that device functions be evaluated with periodic follow up testing by trained personnel to enable review of device performance and associated patient health status throughout the life of the device Warning Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death Immediately following the implant procedure it is recommended that the following procedures be performed 1 Interrogate the pulse generator and review the Device Status screen refer to the EMBLEM S ICD Programmer User s Manual for additional information 2 Perform sensing optimization refer to Setting up the EMBLEM S ICD Pulse Generator page 65 for instructions on performing Automatic Setup including sensing optimization 3 Follow the on screen instructions to capture a reference S ECG 4 Print the Summary Report Captured S ECG Report and Episode Report s to retain in the patient s files for future reference 5 End session During a follow up procedure it is recommended that the location of the subcutaneous electrode be periodically verified by palpation and or X ray When device communication with the programmer is established the programmer automatically notifies the physician of any unusual conditions Refer to the EMBLEM S ICD Programmer User s Manual for more info
11. Lateral and Prone Note f the S ICD System is to be implanted with a concomitant pacemaker all ventricular morphologies paced and intrinsic if normal conduction is expected should be collected Evaluating the Surface ECG Each surface ECG should be evaluated by analyzing at least 10 seconds of QRS complexes If multiple morphologies are noted e g bigeminy pacing etc all morphologies should be tested as described below before the vector is deemed acceptable 38 Each QRS complex is evaluated as follows 1 Select the colored profile from the Patient Screening Tool that best matches the amplitude of the QRS Figure 5 For biphasic signals the larger peak should be used to determine the appropriate colored profile The QRS peak must fall within the window bounded by the dotted line and the peak of the colored profile Note ECG gains gt 20 mm mV are not permitted If when printed at the maximum 20 mm mV gain the QRS peak does not reach the minimum boundary dotted line of the smallest colored profile that QRS complex is deemed unacceptable INCORRECT CORRECT PROFILE PROFILE s uoz e d 2 SELECT the colored profile The largest QRS peak must be within a Peak Zone Figure 5 Selecting the colored profile 2 Align the left edge of the selected colored profile with the onset of the QRS complex The horizontal line on the colored profile should be used as a guide for isoelectric baseline alignment 39 3
12. S ECG data is stored for each treated episode First Shock 44 seconds prior to capacitor charging up to 24 seconds prior to shock delivery and up to 12 seconds of post shock S ECG Subsequent Shocks A minimum of 6 seconds of pre shock and up to 6 seconds post shock S ECG Untreated Episodes For untreated episodes 44 seconds of pre episode and up to 84 seconds of episode S ECG are stored A return to normal sinus rhythm during an untreated episode halts S ECG storage Captured S ECG The S ECG can be captured in real time on rhythm strips when the device is actively linked via wireless telemetry to the programmer Up to fifteen 12 second recordings of S ECG can be stored 49 5 ECG Rhythm Strip Markers The system provides S ECG annotations Table 13 to identify specific events during a recorded episode Sample annotations are shown for the programmer display Figure 9 and the printed report Figure 10 Table 13 5 ECG Markers on Programmer Display Screens and Printed Reports Description Charging Sensed Beat Noisy Beat Paced Beat Tachy Detection Discard Beat Return to NSR Shock Episode data compressed or not available 4 Marker present on printed report but not on programmer display screen 50 Figure 10 Printed Report Markers Patient Data The device can store the following patient data which can be retrieved and updated through the programmer Patient s name Physician s name and co
13. any other subcutaneously implanted medical devices or components for example an implantable insulin pump drug pump or ventricular assist device Figure 15 Connecting the distal end of the subcutaneous electrode to the EIT 3 Using conventional suture material tie the anchoring hole of the subcutaneous electrode to the EIT creating a long 15 16 cm loop Figure 15 58 4 With the subcutaneous electrode attached carefully pull the EIT back through the tunnel to the xiphoid incision until the proximal sensing electrode emerges 5 Place a suture sleeve over the subcutaneous electrode shaft 1 cm below the proximal sensing electrode Using the preformed grooves bind the suture sleeve to the subcutaneous electrode shaft using 2 0 silk or similar non absorbable suture material making sure not to cover the proximal sensing electrode Check the suture sleeve after anchoring to assure stability by grasping the suture sleeve with fingers and trying to move the subcutaneous electrode in either direction Note Do not secure the suture sleeve and subcutaneous electrode to the fascia until electrode placement is complete 6 Makea second incision approximately 14 cm superior to the xiphoid incision superior incision If desired place the exposed subcutaneous electrode on the skin to make this measurement The distance between the superior and xiphoid incisions must accommodate the portion of the subcutaneous electrode from the distal sensing ele
14. can result in the patient s death Pulse generator interaction Using multiple pulse generators could cause pulse generator interaction resulting in patient injury or a lack of therapy delivery Test each system individually and in combination to help prevent undesirable interactions Refer to the S ICD System and Pacemaker Interaction section on page 83 of this manual for more information Co implanted device interaction Concomitant use of the S ICD System and implanted electro mechanical devices for example a ventricular assist device VAD or implantable insulin pump or drug pump can result in interactions that could compromise the function of the S ICD the co implanted device or both Electromagnetic interference EMI or therapy delivery from the co implanted device can interfere with S ICD sensing and or rate assessment resulting in inappropriate therapy or failure to deliver therapy when needed In addition a shock from the S ICD pulse generator could damage the co implanted device and compromise its functionality To help prevent undesirable interactions test the S ICD System when used in combination with the co implanted device and consider the potential effect of a shock on the co implanted device Proper Handling Handle the components of the S ICD System with care at all times and maintain proper sterile technique Failure to do so may lead to injury illness or death of the patient Do not damage components Do not modify cu
15. cardioversion or defibrillation verify pulse generator function Post Therapy Pulse Generator Follow Up on page 13 Cardiopulmonary resuscitation Cardiopulmonary resuscitation CPR may temporarily interfere with sensing and may cause delay of therapy Electrical interference Electrical interference or noise from devices such as electrocautery and monitoring equipment may interfere with establishing or maintaining telemetry for interrogating or programming the device In the presence of such interference move the programmer away from electrical devices and ensure that the wand cord and cables are not crossing one another Electrical interference or noise from concomitant implanted devices such as a ventricular assist device VAD drug pump or insulin pump may interfere with establishing or maintaining telemetry for interrogating or programming the pulse generator In the presence of such interference place the wand over the pulse generator and shield both with a radiation resistant material Ionizing Radiation It is not possible to specify a safe radiation dosage or guarantee proper pulse generator function following exposure to ionizing radiation Multiple factors collectively determine the impact of radiation therapy on an implanted pulse generator including proximity of the pulse generator to the radiation beam type and energy level of the radiation beam dose rate total dose delivered over the life of the pulse ge
16. conversion test that the patient s tachyarrhythmias can be detected and terminated by the pulse generator system if the patient s status has changed or parameters have been reprogrammed Follow up considerations for patients leaving the country Pulse generator follow up considerations should be made in advance for patients who plan to travel or relocate post implant to a country other than the country in which their device was implanted Regulatory approval status for devices and associated programmer software configurations varies by country certain countries may not have approval or capability to follow specific products Contact Boston Scientific using the information on the back cover for help in determining feasibility of device follow up in the patient s destination country Explant and Disposal Device handling at explant Before explanting cleaning or shipping the device complete the following actions to prevent unwanted shocks overwriting of important therapy history data and audible tones gt Program the pulse generator to Therapy Off mode If ERI or EOL has been reached disable the beeper gt Clean and disinfect the device using standard biohazard handling techniques Incineration Be sure that the pulse generator is removed before cremation Cremation and incineration temperatures might cause the pulse generator to explode Supplemental Precautionary Information Post Therapy Pulse Generator Follow Up Fo
17. of charging cycles shorten the battery longevity Pediatric Use The S ICD System has not been evaluated for pediatric use e Available Therapies The S ICD System does not provide long term bradycardia pacing cardiac resynchronization therapy CRT or anti tachycardia pacing ATP Sterilization and Storage If package is damaged The blister trays and contents are sterilized with ethylene oxide gas before final packaging When the pulse generator and or subcutaneous electrode is received it is sterile provided the container is intact If the packaging is wet punctured opened or otherwise damaged return the pulse generator and or subcutaneous electrode to Boston Scientific If device is dropped Do not implant a device which has been dropped while outside of its intact shelf package Do not implant a device which has been dropped from a height of more than 24 inches 61 cm while within its intact shelf package Sterility integrity and or function cannot be guaranteed under these conditions and the device should be returned to Boston Scientific for inspection Use by date Implant the pulse generator and or subcutaneous electrode before or on the USE BY date on the package label because this date reflects a validated shelf life For example if the date is January 1 do not implant on or after January 2 Device storage Store the pulse generator in a clean area away from magnets kits containing magnets and sources of EMI
18. placed in a lateral location at the 5th intercostal space along the mid axillary line to represent the intended location of the implanted pulse generator ECG Electrode LA should be placed 1 cm left lateral of the xiphoid midline to represent the intended location of the proximal sensing node of the implanted subcutaneous electrode 37 ECG Electrode RA should be placed 14 cm superior to the ECG Electrode LA to represent the intended position of the distal sensing tip of the implanted subcutaneous electrode A 14 cm guide is located at the bottom of the transparent screening tool SIMULTANEOUS 3 LEAD ECG RA oy TA O cao P 1 RECORD Supine Standing 25 mm s 5 20 mm mV Figure 4 Typical placement of surface ECG electrodes for patient screening 2 Using a standard ECG machine record 10 20 seconds of ECG using Leads II and III with a sweep speed of 25 mm sec and ECG gain between 5 20 mm mV use the largest ECG gain that does not result in clipping Note t is important to establish a stable baseline when collecting the surface ECG Ifa wandering baseline is noted ensure that the appropriate ground electrodes from the ECG machine are attached to the patient To yield an acceptable signal for testing the gain may be adjusted for each ECG lead independently 3 Record ECG signals in at least two postures 1 Supine and 2 Standing Other postures may be collected including Seated Left Lateral Right
19. possibly leading to compromised sensing loss of therapy or inappropriate therapy Caution Do not bend the subcutaneous electrode near the subcutaneous electrode header interface Improper insertion can cause insulation or connector damage Note fnecessary lubricate the connector sparingly with sterile water to make insertion easier 63 4 Apply gentle downward pressure on the torque wrench until the blade is fully engaged within the setscrew cavity taking care to avoid damage to the seal plug Tighten the setscrew by slowly turning the torque wrench clockwise until it ratchets once The torque wrench is preset to apply the proper amount of force to the captive setscrew additional rotation and force is unnecessary 5 Remove the torque wrench 6 Apply gentle traction to the subcutaneous electrode to ensure a secure connection 7 Ifthe subcutaneous electrode terminal is not secure attempt to reseat the setscrew Reinsert the torque wrench as described above and loosen the setscrew by slowly turning the wrench counterclockwise until the subcutaneous electrode is loose Then repeat the sequence above 8 Insert the device into the subcutaneous pocket with any excess subcutaneous electrode placed underneath the device 9 Anchor the device to the fascia to prevent possible migration using conventional 0 silk or similar non absorbable suture material Two suture holes are provided in the header for this purpose Figure 20 10 Fl
20. pulse generator to Therapy Off mode 2 Observe real time S ECGs at prescribed TENS output settings noting when appropriate sensing or interference occurs 3 When finished turn off the TENS unit and reprogram the pulse generator to Therapy On mode You should also perform a thorough follow up evaluation of the pulse generator following TENS to ensure that device function has not been compromised Post Therapy Pulse Generator Follow Up on page 13 For additional information contact Boston Scientific using the information on the back cover Home and Occupational Environments Home appliances Home appliances that are in good working order and properly grounded do not usually produce enough EMI to interfere with pulse generator operation There have been reports of pulse generator disturbances caused by electric hand tools or electric razors used directly over the pulse generator implant site Electronic Article Surveillance EAS and Security Systems Advise patients how to avoid impact to cardiac device function due to antitheft and security gates tag deactivators or tag readers that include radio frequency identification RFID equipment These systems may be found at the entrances and exits of stores at checkout counters in public libraries and in point of entry access control systems Patients should avoid lingering near or leaning against antitheft and security gates and tag readers In addition patients should avoid le
21. request 1 Patient Deaths Eight 8 deaths occurred in the study None of the deaths were conclusively identified to be associated with the device or procedure Effectiveness Results The effectiveness of the S ICD System was assessed by the proportion of patients with successful acute induced VF conversion in all patients with an attempted S ICD System implant N 320 A successful VF conversion test required two consecutive VF conversions at 65 J from four induction attempts within a given shock polarity Of the 320 patients who underwent acute VF conversion testing 16 patients yielded non evaluable results due to incomplete protocol testing Of the 304 evaluable results the S ICD System acute VF conversion success rate was 100 with a lower 95 confidence bound of 98 8 Table 10 These results met the primary safety endpoint performance goal of 88 and demonstrate the effectiveness of the S ICD System 2 One 1 patient did not undergo testing at the discretion of the investigator 3 Nine 9 patients were implanted with the S ICD System Seven 7 patients with non evaluable tests were not implanted Five 5 of the seven 7 patients received a transvenous ICD and information regarding subsequent device implantation for two 2 patients is unknown 32 Table 10 Effectiveness Endpoint Result Acute VF Conversion Rate Patients undergoing acute VF conversion testing N 320 Evaluable Results 9 x Non Estimate 95 Clopp
22. the tools provided in the device tray Failure to use the supplied tools may result in damage to the setscrew Retain the tools until all testing procedures are complete and the device is implanted Caution Verify the device is in Shelf mode or Therapy Off to prevent the delivery of unwanted shocks to the patient or the person handling the device during the implant procedure Note Avoid allowing blood or other body fluids to enter the connector port in the device header If blood or other body fluids inadvertently enter the connector port flush with sterile water Note Do not implant the device if the setscrew seal plug appears to be damaged 1 Ifapplicable remove and discard the tip protection before using the torque wrench 2 Gently insert the torque wrench blade into the setscrew by passing it through the preslit center depression of the seal plug at a 90 angle Figure 18 This will open up the seal plug relieving any potential pressure build up from the connector port by providing a pathway to release trapped fluid or air Note Failure to properly insert the torque wrench in the preslit depression of the seal plug may result in damage to the plug and its sealing properties Caution Do not insert the subcutaneous electrode into the pulse generator connector port without taking the following precautions to ensure proper insertion Insert the torque wrench into the preslit depression of the seal plug before inserting the subcuta
23. to avoid device damage Storage temperature and equilibration Recommended storage temperatures are 0 C 50 C 32 F 122 F Allow the device to reach a proper temperature before using telemetry communication capabilities programming or implanting the device because temperature extremes may affect initial device function Implantation Avoid shock at implant Verify the device is in Shelf mode or Therapy Off to prevent the delivery of unwanted shocks to the patient or the person handling the device during the implant procedure Evaluate patient for surgery There may be additional factors regarding the patient s overall health and medical condition that while not related to device function or purpose could render the patient a poor candidate for implantation of this system Cardiac health advocacy groups may have published guidelines that may be helpful in conducting this evaluation Creating the subcutaneous tunnel Use only the electrode insertion tool to create the subcutaneous tunnel when implanting and positioning the subcutaneous electrode Avoid tunneling close to any other subcutaneously implanted medical devices or components for example an implantable insulin pump drug pump or ventricular assist device Suture location Suture only those areas indicated in the implant instructions Do not suture directly over subcutaneous electrode body Do not suture directly over the subcutaneous electrode body as this may caus
24. 4 Evaluate the QRS complex If the entire QRS complex and trailing T wave are contained within the colored profile the QRS is deemed acceptable If any portion of the QRS complex or trailing T wave extends outside of the colored profile the QRS is deemed unacceptable Figure 6 UNACCEPTABLE ACCEPTABLE LEAD LEAD DN 3 VERIFY at least one lead is acceptable in all postures Figure 6 Evaluating the QRS complex Repeat the above steps with all QRS complexes collected with all surface ECG leads in all collected postures Determining an Acceptable Sense Vector Each collected surface ECG lead represents a sense vector of the S ICD System Evaluate each surface ECG lead independently for acceptability A surface ECG lead sense vector should be deemed acceptable only if all of the following conditions are met All tested QRS complexes and morphologies from the surface ECG lead sense vector must pass the QRS evaluation Exceptions can be made for a large morphology change associated with an occasional ectopic beat e g PVC The morphology of the intrinsic paced QRS complex is stable across postures No significant change to the QRS complex is noted as a result of postural changes The surface ECG lead sense vector must be deemed acceptable in all tested postures A patient is considered suitable for implant of the S ICD System if at least one surface ECG lead sense vector is acceptable for all tested postures 40
25. 6 46 46 46 47 47 Arrhythmia Induction System Diagnostics Subcutaneous Electrode Impedance Device Integrity Check Battery Performance Monitoring System Storing and Analyzing Data Treated Episodes Untreated Episodes Captured S ECG S ECG Rhythm Strip Markers Patient Data S ICD System Magnet Use Magnet use for patients with deep implant placement Magnet Response and Pulse Generator Mode Bidirectional Torque Wrench Using the EMBLEM S ICD Pulse Generator Items Included in Package Implanting the S ICD System Check Equipment Interrogate and Check the Pulse Generator Creating the Device Pocket Implanting the EMBLEM S ICD Subcutaneous Electrode Connecting the Subcutaneous Electrode to the Device Setting up the EMBLEM S ICD Pulse Generator using the Model 3200 S ICD Programmer Defibrillation Testing Complete and Return the Implantation Form Patient Counseling Information Patient Guide Post Implant Follow Up Procedures Explantation Loosening Stuck Setscrews 47 47 48 48 48 49 49 49 49 50 51 52 53 54 55 55 55 56 56 57 57 58 61 65 66 67 68 68 69 70 71 Communication Compliance Federal Communications Commission FCC Compliance Additional Information Product Reliability Pulse Generator Longevity Specifications X ray Identifier Definitions of Package Label Symbols S ICD System and Pacemaker Interaction Warranty Information 72 72 72 72 73 74 74 81 83 84 Description The EMBLEM
26. 9 Hematoma 1 1 0 3 5 4 1 2 6 5 1 6 Inadequate Prolonged Healing of 3 3 0 9 2 2 0 6 5 5 1 6 Incision Site 29 30 Clinical Event Complications Events Patients Observations Events Patients Events Patients Inappropriate Shock SVT Above Discrim ination Zone Normal Device Function Incision Superficial 4 4 1 2 17 14 4 4 21 16 5 0 Infection Keloid Local Tissue Reaction Numbness at Device Site PG Movement Revision Phantom Shock Redness Irritation f Stroke Clinical Event Complications Patients Observations Patients Patients Sub optimal PG and Electrode Position Sub optimal Pulse Generator Position Suspected Worsening of Ischemia System Infection 1 0 3 4 1 2 0 0 0 1 0 3 0 0 0 4 1 2 All Type Ill Clinical Events 24 7 5 71 22 1 88 27 4 31 Device Explants Eleven 11 patients exited the study after the S ICD System was removed for system infection 4 oversensing 2 pre mature battery depletion 1 transvenous device implanted to provide overdrive pacing for ventricular arrhythmia trigger suppression 1 elective explant due to the development of an indication for biventricular pacing 1 elective explant due to development of high defibrillation threshold 1 and elective due to patient
27. Certified Event Compare Current Certified Event and NSR Template Poor Match Good Match Compare QRS Width to Threshold Good Match Poor Match Narrow Wide Label S Label T Label s Label T Normal Sensed Event Tachy Detection Normal Sensed Event Wide QRS Treatable Non Treatable Event Treatable Event Non Treatable Event Event Figure 8 Decision tree for determining treatable arrhythmias in the Conditional Shock Zone For some patients a NSR Template may not be formed during device initialization as a result of variability in their cardiac signal at resting heart rates For such patients the device uses beat to beat morphology and QRS width analysis for arrhythmia discrimination 44 Charge Confirmation The device must charge the internal capacitors before shock delivery Confirmation of the ongoing presence of a tachyarrhythmia requires monitoring a moving window of the 24 most recent intervals defined by certified events Charge confirmation employs an X treatable interval out of Y total intervals in the window strategy to accomplish this If 18 of the 24 most recent intervals are found to be treatable the device begins to analyze rhythm persistence Persistence analysis requires the X out of Y condition be maintained or exceeded for at least two consecutive intervals however this value may be increased as a result of Smart Charge as explain
28. Subcutaneous Electrode The procedure described below is one of several surgical approaches that can be used to appropriately implant and position the electrode Regardless of the surgical approach the defibrillation coil must be positioned parallel to the sternum in close proximity to or in contact with the deep fascia approximately 2 cm from the sternal midline Figure 73 In addition good tissue contact with the electrode and pulse generator is important to optimize sensing and therapy delivery Use standard surgical techniques to obtain good tissue contact For example keep the tissue moist and flushed with sterile saline express any residual air out through the incisions prior to closing and when closing the skin take care not to introduce air into the subcutaneous tissue 1 Make a small 2 cm horizontal incision at the xiphoid process xiphoid incision Note f desired in order to facilitate attachment of the suture sleeve to the fascia following electrode placement two suture ties to the fascia can be made at the xiphoid incision prior to continuing 2 Insert the distal tip of the EIT at the xiphoid incision and tunnel laterally until the distal tip emerges at the device pocket Note The EIT is malleable and can be curved to match the patient s anatomical profile Caution Use only the electrode insertion tool to create the subcutaneous tunnel when implanting and positioning the subcutaneous electrode Avoid tunneling close to
29. able that the inframammary crease was cited in 2 cases of female discomfort and the interface between the device site and the patient s bra was cited in another case Race African American race was not associated with device or procedure related complications Dual Zone Programming at Discharge Dual zone programming at the time of hospital discharge was associated with significantly fewer inappropriate shocks than those programmed with a single zone There was a 70 relative reduction of incidence for inappropriate shocks due to SVT and a 56 relative reduction of incidence for inappropriate shocks due to oversensing when compared to single zone programming 35 Conclusion The purpose of the S ICD System Clinical Investigation was to evaluate the safety effectiveness and chronic performance of the S ICD System There were 330 patients enrolled in the study and 321 underwent an implant procedure The 314 patients implanted with the S ICD System generated 3 410 months of patient data The data demonstrate that the S ICD System operates appropriately per design for the S ICD System s intended uses and as described in the S ICD System s labeling All objectives of the S ICD System Clinical Investigation were met demonstrating safety and effectiveness of the S ICD System 36 Patient Screening The patient screening tool Model 4744 Figure 3 is a customized measurement tool made of transparent plastic printed with colored profiles The p
30. aneous electrode 70 Interrogate the pulse generator and print all reports Deactivate the pulse generator before explantation Disconnect the subcutaneous electrode from the pulse generator e If subcutaneous electrode is explanted attempt to remove it intact and return it regardless of condition Do not remove the subcutaneous electrode with hemostats or any other clamping tool that may damage it Resort to tools only if manual manipulation cannot free the subcutaneous electrode Wash but do not submerge the pulse generator and subcutaneous electrode to remove body fluids and debris using a disinfectant solution Do not allow fluids to enter the pulse generator s connector port Use a Boston Scientific Returned Product Kit to properly package the pulse generator and or subcutaneous electrode and send it to Boston Scientific Loosening Stuck Setscrews Follow these steps to loosen stuck setscrews 1 From a perpendicular position tilt the torque wrench to the side 20 to 30 from the vertical center axis of the setscrew Figure 22 Rotate the wrench clockwise for retracted setscrew or counterclockwise for extended setscrew around the axis three times such that the handle of the wrench orbits the centerline of the screw Figure 22 The torque wrench handle should not turn or twist during this rotation 1 Clockwise rotation to free setscrews stuck in the retracted position 2 Counterclockwise rot
31. aning against checkout counter mounted and handheld tag deactivation systems Anti theft gates security gates and entry control systems are unlikely to affect cardiac device function when patients walk through them at a normal pace If the patient is near an electronic antitheft security or entry control system and experiences symptoms they should promptly move away from nearby equipment and inform their doctor Cellular phones Advise patients to hold cellular phones to the ear opposite the side of the implanted device Patients should not carry a cellular phone that is turned on in a breast pocket or on a belt within 15 cm 6 inches of the implanted device since some cellular phones may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy Magnetic fields Advise patients that extended exposure to strong greater than 10 gauss or 1 mTesla magnetic fields may suspend arrhythmia detection Examples of magnetic sources include Industrial transformers and motors gt MRI scanners Large stereo speakers Telephone receivers if held within 1 27 cm 0 5 inches of the pulse generator gt Magnetic wands such as those used for airport security and in the Bingo game Elevated Pressures The International Standards Organization ISO has not approved a standardized pressure test for implantable pulse generators that experience hyperbaric oxygen therapy HBOT or SCUBA diving However Boston Scientific dev
32. arks However it is recommended to review a pre implant chest x ray in order to confirm that a patient does not have notably atypical anatomy e g dextrocardia Additionally it is not recommended to deviate from the implant instructions to accommodate for physical body size or habitus unless a pre implant chest x ray has been reviewed The device and subcutaneous electrode are typically implanted subcutaneously in the left thoracic region Figure 13 The EIT is used to create the subcutaneous tunnels in which the electrode is inserted Figure 13 Placement of the S ICD System Check Equipment It is recommended that instrumentation for cardiac monitoring and defibrillation be available during the implant procedure This includes the S ICD System Programmer with its related accessories and the software application Before beginning the implantation procedure become completely familiar with the operation of all the equipment and the information in the respective user s manuals Verify the operational status of all equipment that may be used during the procedure In case of accidental damage or contamination the following should be available Sterile duplicates of all implantable items Wand ina sterile barrier Torque and non torque wrenches During the implantation procedure always have a standard transthoracic defibrillator with external pads or paddles available for use during defibrillation threshold testing 56 Interrog
33. as any untoward medical occurrence in a patient An Observation is a clinical event that does not result in invasive intervention and a Complication is a clinical event that results in invasive intervention All clinical events were classified by type based on the cause of the clinical event according to the following definitions Type Caused by the S ICD System Type Il Caused by the S ICD System user s manual or labeling of the S ICD System Type lil Not caused by the S ICD System but would not have occurred in the absence of the implanted S ICD System Type IV Caused by a change in the patient s condition Table 6 summarizes all 211 clinical events reported from 139 patients followed by a full listing of all Type II and III clinical events in Table 7 Table 8 and Table 9 respectively 25 Table 6 Clinical Event Summary by Type and Observation Complication All patients with an implant attempt N 321 Complications Observations Total Clinical Event Patients Patients Patients Events Events Events 11 3 4 3 12 1 4 1 2 4 1 2 24 7 5 Type IV 15 4 7 All Clinical 48 15 0 Events a Of note there were a total of 12 Type Complications throughout the entire follow up duration Three 3 occurred within 180 days of implant and are shown in the primary safety Kaplan Meier analysis Figure 2 Five 5 additional Type complications were observed within 360 days
34. ate and Check the Pulse Generator To maintain sterility test the pulse generator as described below before opening the sterile blister tray The pulse generator should be at room temperature to ensure accurately measured parameters 1 2 3 Place the wand directly over the pulse generator From the programmer startup screen select the Scan for Devices button Identify the pulse generator being implanted from the Device List screen and verify that the status of the pulse generator is reported as Not Implanted This indicates the pulse generator is in Shelf Mode If otherwise contact Boston Scientific using the information on the back cover From the Device List screen select the pulse generator being implanted to initiate a communication session Upon connection with the pulse generator the programmer will display an alert if the pulse generator battery status is below the appropriate level for a device at implant If a battery alert appears contact Boston Scientific using the information on the back cover Creating the Device Pocket The device is implanted in the left lateral thoracic region To create the device pocket make an incision such that the device can be placed in the vicinity of the left 5th and 6th intercostal spaces and near the mid axillary line Figure 14 This can be accomplished by making an incision along the inframammary crease Figure 14 Creating the device pocket 57 Implanting the EMBLEM S ICD
35. ation to free setscrews stuck in the extended position Figure 22 Rotating the torque wrench to loosen a stuck setscrew As needed you may attempt this up to four times with slightly more angle each time If you cannot fully loosen the setscrew use the 2 torque wrench from Wrench Kit Model 6501 Once the setscrew has been freed it may be extended or retracted as appropriate Discard the torque wrench upon completion of this procedure 71 Communication Compliance Federal Communications Commission FCC Compliance This transmitter is authorized by rule under the Medical Device Radiocommunication Service in part 95 of the FCC Rules and must not cause harmful interference to stations operating in the 400 150 406 000 MHz band in the Meteorological Aids i e transmitters and receivers used to communicate weather data the Meteorological Satellite or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations including interference that may cause undesired operation This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service Analog and digital voice communications are prohibited Although this transmitter has been approved by the Federal Communications Commission there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference This transmit
36. clinical implication of the malfunction When Boston Scientific communicates product advisory information the decision whether to replace a device should take into account the risks of the malfunction the risks of the replacement procedure and the performance to date of the replacement device Pulse Generator Longevity Based on simulated studies it is anticipated that these pulse generators have average longevity to EOL as shown below At the time of manufacture the device has the capacity for over 100 full energy charges shocks The average projected longevity which accounts for the energy used during manufacture and storage assumes the following conditions 2 maximum energy charges at implant and 6 maximum energy charges shocks in the final 3 month period between ERI and EOL The pulse generator spends 6 months in Shelf mode during shipping and storage Telemetry use for 1 hour at implant and 30 minutes annually for in clinic follow up checks Standard use of the LATITUDE Communicator as follows Weekly Device Check monthly Full Interrogations scheduled remote follow ups and quarterly patient initiated interrogations With stored Episode Report Onset EGM Table 15 Device longevity Annual Full Energy Charges Average Projected Longevity years 3 Normal se deals AE enn E ener 5 6 3 The median number of annual full energy charges seen in clinical testing of the first generation S ICD system was 3 3 Note T
37. ctrode to the proximal sensing electrode Pre place one or two fascial sutures in superior incision Use a non absorbable suture material of appropriate size for long term retention Apply gentle traction to ensure adequate tissue fixation Retain the needle on the suture for later use in passing through the electrode anchoring hole 7 Insert the distal tip of the EIT into the xiphoid incision and tunnel subcutaneously towards the superior incision staying as close to the deep fascia as possible Figure 76 A Figure 16 Tunneling to Superior Incision 8 Once the distal tip of the EIT emerges from the superior incision disconnect and retain the suture loop from the distal tip of the EIT Secure the ends of the suture with a surgical clamp Remove the EIT 59 60 10 11 12 13 14 Using the secured suture at the superior incision carefully pull the suture and subcutaneous electrode through the tunnel until the anchoring hole emerges The subcutaneous electrode should be parallel to the sternal midline with the defibrillation coil in close proximity to the deep fascia Cut and discard the suture material At the xiphoid incision secure the suture sleeve with the subcutaneous electrode to the fascia using 2 0 silk or similar non absorbable suture material Warning Use appropriate anchoring techniques as described in the implant procedure to prevent S ICD System dislodgement and or migration Dislodgement and or migra
38. d reported on the programmer screen just after the shock is delivered Reported shock impedance values should be within 25 200 ohms A reported value of greater than 200 ohms will activate the internal warning system Caution A reported shock impedance value of less than 25 ohms from a delivered shock could indicate a problem with the device The delivered shock may have been compromised and or any future therapy from the device may be compromised If a reported impedance value of less than 25 ohms is observed correct functioning of the device should be verified Note Measurement of electrode impedance either by the sub threshold measurement or during shock delivery may not detect a loose setscrew due to the location of the setscrew at the electrode tip Device Integrity Check The Device Integrity Check is automatically performed daily by the implanted system and also each time the programmer communicates with an implanted device This test scans for any unusual conditions in the device and if any are detected the system provides a notification either via the pulse generator s internal warning system or on the programmer screen Battery Performance Monitoring System The device automatically monitors battery status to provide notice of impending battery depletion Two indicators are provided via messages on the programmer each activated by declining battery voltage ERI and EOL are also signaled by activation of the device s beeper
39. ditional details can be found in the EMBLEM S ICD Model 3200 Programmer User s Manual This process can be performed automatically or manually during the implant procedure although Automatic Setup is recommended During setup the system automatically Confirms entry of the subcutaneous electrode model and serial numbers Measures the shock electrode impedance Optimizes the sense electrode configuration Optimizes the gain selection Acquires a reference NSR template 65 To initiate the Automatic Setup process 1 After using the programmer to scan for devices choose the device being implanted from the Device List screen 2 The programmer will connect to the chosen pulse generator and the Device Identification screen will appear Choosing the Continue button from this screen removes the pulse generator from Shelf Mode and causes the Automatic Setup screen to appear 3 Select the Automatic Setup button to initiate Automatic Setup 4 Follow the on screen instructions to complete the Automatic Setup sequence If the patient s heart rate is greater than 130 bpm you will be instructed to complete the Manual Setup process instead To initiate the Manual Setup process 1 From the Main Menu screen select the Utilities button 2 From the Utilities screen select the Manual Setup button You will be guided through a manual impedance test selection of sensing vector selection of gain setting and acquisition of a referenc
40. e S ECG Defibrillation Testing Once the device is implanted and programmed to Therapy On defibrillation testing may be conducted A 15J safety margin is recommended for defibrillation testing Note Defibrillation testing is recommended at implant to confirm the ability of the S ICD System to sense and convert VF Warning Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death To induce VF and test the S ICD System using the Model 3200 S ICD programmer 1 Select the Main Menu icon arrow within a circle in the Navigation bar in the top right corner of the screen 2 From the Main Menu screen select the Patient Test button to setup the induction test 3 Follow the on screen instructions to set shock energy and polarity and to induce an arrhythmia Note Ensure that noise markers N are not present on the S ECG prior to induction The presence of noise markers may delay detection and therapy delivery 4 Atany time prior to therapy delivery the programmed energy may be aborted by selecting the red Abort button 66 5 Select the Exit button to exit the induction process and return to the Main Menu screen The following functions occur during the test The S ICD System induces ventricular fibrillation using 200 mA alternating current AC
41. e structural damage Use the suture sleeve to prevent subcutaneous electrode movement Do not bend the subcutaneous electrode near the electrode header interface Insert the subcutaneous electrode connector straight into the pulse generator header port Do not bend the subcutaneous electrode near the subcutaneous electrode header interface Improper insertion can cause insulation or connector damage Subcutaneous Electrode connections Do not insert the subcutaneous electrode into the pulse generator connector port without taking the following precautions to ensure proper insertion gt Insert the torque wrench into the preslit depression of the seal plug before inserting the subcutaneous electrode connector into the port to release any trapped fluid or air Visually verify that the setscrew is sufficiently retracted to allow insertion Use the torque wrench to loosen the setscrew if necessary Fully insert the subcutaneous electrode connector into the port and then tighten the setscrew onto the connector Sternal wires When implanting the S ICD system in a patient with sternal wires ensure that there is no contact between the sternal wires and the distal and proximal sense electrodes for example by using fluoroscopy Compromised sensing can occur if metal to metal contact occurs between a sense electrode and a sternal wire If necessary re tunnel the electrode to ensure sufficient separation between the sense electrodes and the ster
42. ection Symptoms that should be reported e g lightheadedness palpitations unexpected shocks Protected environments the patient should seek medical guidance before entering areas protected by a warning notice that prevents entry by patients who have a pulse generator Avoiding potential sources of EMI in home work and medical environments Persons administering CPR the presence of voltage tingling on the patient s body surface may be experienced when the pulse generator delivers a shock Reliability of their pulse generator Product Reliability on page 72 Activity restrictions if applicable Frequency of follow up Travel or relocation Follow up arrangements should be made in advance if the patient is leaving the country of implant Patient ID card the patient should be advised to carry their patient ID card at all times a temporary patient ID card is provided with the device and a permanent ID card will be sent to the patient 4 to 6 weeks after the implant form is received by Boston Scientific A copy of the Patient Guide is available for the patient patient s relatives and other interested people It is recommended that you discuss the information in the Patient Guide with concerned individuals both before and after implantation so they are fully familiar with pulse generator operation For additional copies contact Boston Scientific using the information on the back cover 68 Post Implant Follow Up Procedures
43. ed below Capacitor charging is initiated when the following three conditions are met 1 XofY criterion is satisfied 2 Persistence requirement is satisfied 3 The last two certified intervals are in the treatable zone Therapy Delivery Rhythm analysis continues throughout the capacitor charging process Therapy delivery is aborted if the 4 RR average interval becomes longer in ms than the lowest rate zone plus 40 ms for 24 intervals When this occurs an untreated episode is declared and a Smart Charge extension is incremented as explained below Capacitor charging continues until the capacitor has reached its target voltage at which time reconfirmation is performed Reconfirmation is used to ensure that the treatable rhythm did not spontaneously terminate during the charging cycle Reconfirmation requires the last three consecutive detected intervals regardless of whether the intervals are certified or suspect to be faster than the lowest therapy zone If non treatable events are detected during or after the charging sequence reconfirmation is automatically extended one interval at a time up to a maximum of 24 intervals Reconfirmation is always performed and shock delivery is non committed until reconfirmation is complete Once the criteria for reconfirmation are met the shock is delivered Smart Charge Smart Charge is a feature that automatically increases the Persistence requirement by three intervals each time an untreated ep
44. eloped a test protocol to evaluate device performance upon exposure to elevated atmospheric pressures The following summary of pressure testing should not be viewed as and is not an endorsement of HBOT or SCUBA diving Elevated pressures due to HBOT or SCUBA diving may damage the pulse generator During laboratory testing all pulse generators in the test sample functioned as designed when exposed to more than 300 cycles at a pressure up to 3 0 ATA Laboratory testing did not characterize the impact of elevated pressure on pulse generator performance or physiological response while implanted in a human body Pressure for each test cycle began at ambient room pressure increased to a high pressure level and then returned to ambient pressure Although dwell time the amount of time under elevated pressure may have an impact on human physiology testing indicated it did not impact pulse generator performance Pressure value equivalencies are provided below Table 1 on page 12 Table 1 Pressure Value Equivalencies Pressure value equivalencies Atmospheres Absolute 3 0 ATA Sea water depth 20 m 65 ft Pressure absolute All pressures were derived assuming sea water density of 1030 kg m3 b pressure as read on a gauge or dial psia psig 14 7 psi Prior to SCUBA diving or starting an HBOT program the patient s attending cardiologist or electrophysiologist should be consulted to fully understand the potential consequences relative
45. er evaluable Pearson Interval Results Successful Failure 16 304 100 0 98 8 100 0 Of the 16 non evaluable patients 11 were associated with at least one failed conversion attempt at 65 J and due to physician discretion did not exhaust all of the protocol defined induction attempts in both shock polarities A sensitivity analysis was performed to impute these patients as failures despite incomplete testing resulting in an imputed VF conversion success rate of 96 5 Spontaneous Episodes A total of 119 spontaneous VT VF episodes in 21 patients were treated by the S ICD System through February 14 2012 A VT VF episode refers to a device declared episode in which device rate discrimination criteria were met in response to a ventricular tachyarrhythmia and therapy was delivered A single episode may contain up to 5 shocks The episode ends when the rolling average of the rate falls below the lowest programmed rate zone for 24 consecutive intervals For analysis episodes were sub divided into two classes 1 discrete episodes that were temporally independent lt 3 within 24 hours and 2 VT VF storms that comprise 3 or more treated VT VF episodes within 24 hours in the same patient Of the 38 discrete device episodes 35 92 1 were converted with the first shock and 37 97 4 were converted by any shock Table 11 One episode terminated spontaneously after an unsuccessful first shock MVT Four 4 VT VF storms from 2 patie
46. g Capacitor Reform Schedule Internal Warning System Parameter Value DETECTION RHYTHM DISCRIMINATION X Y for Initial Detection 18 24 intervals X Y for Redetection 14 24 intervals Confirmation Before Shock ity Refractory Period 3 24 consecutive tachy intervals Fast 160 ms Slow 200 ms FIBRILLATION INDUCTION Frequency Output Time out After Activation SENSING Minimum Sensing Threshold CAPACITOR REF Automatic Capacitor Reformation Interval 08 mV ORM SCHEDULE Approximately 4 months INTERNAL WARNING SYSTEM High Impedance sub threshold High Impedance delivered shock Maximum Charge Time out a With 10 Hz sine wave gt 400 Ohms gt 200 Ohms 44 sec b Reform can be delayed if capacitor was charged due to sus ained non sustained arrhythmia in past 4 months 79 80 Table 21 Episode Data Parameters Parameter Treated Episodes Untreated Episodes Maximum Length per s ECG Episode Captured S S ECG Report Table 22 Stored Patient Information Patient Information Stored Data Patient Name Physician Name Device Serial Number Electrode Model Number Patient Notes Value 25 stored 20 stored 128 sec Up to 15 12 sec each Physician Contact Information Device Model Number Electrode Serial Number Table 23 Magnet Specifications Model 6860 Component Specification Shape Circular Approximate Diameter 2 8 in 7 2 cm Size
47. g and that capacitor charging is imminent Ifa high degree of amplitude variation is noted during the arrhythmia a slight delay may be expected prior to capacitor charging or shock delivery If appropriate sensing or VF conversion cannot be demonstrated consider changing the selected sense configuration or relocating the subcutaneous electrode or device and then retest VF conversion testing can be conducted in either polarity Complete and Return the Implantation Form Within ten days of implantation complete the Warranty Validation and Lead Registration form and return the original to Boston Scientific along with copies of the Summary Report Captured S ECG Report and Episode Report s printed from the programmer This information enables Boston Scientific to register each implanted pulse generator and subcutaneous electrode and provide clinical data on the performance of the implanted system Keep a copy of the Warranty Validation and Lead Registration form and programmer printouts for the patient s file 67 Patient Counseling Information The following topics should be discussed with the patient prior to discharge Patient Guide External defibrillation the patient should contact their physician to have their pulse generator system evaluated if they receive external defibrillation Beeping tones the patient should contact their physician immediately if they hear tones coming from their pulse generator Signs and symptoms of inf
48. gBostons cient PULSE GENERATOR USER S MANUAL EMBLEM S ICD Subcutaneous Implantable Cardioverter Defibrillator MODEL A209 CAUTION Federal law USA restricts this device to sale by or on the order of a physician trained or experienced in device implant and follow up procedures EMBLEM is a trademark of Boston Scientific This product may be protected by one or more patents Patent information can be obtained at http www bostonscientific com patents List of Acronyms ATP Anti tachycardia pacing BOL Beginning of life CPR Cardiopulmonary resuscitation CRT Cardiac resynchronization therapy DFT Defibrillation threshold EAS Electronic article surveillance ECG Electrocardiogram EGM Electrogram EIT Electrode insertion tool EMI Electromagnetic interference EOL End of life ERI Elective replacement indicator ESWL Extracorporeal shock wave lithotripsy FCC Federal Communications Commission HBOT Hyperbaric oxygen therapy MRI Magnetic resonance imaging NSR Normal sinus rhythm PVC Premature ventricular contraction S ECG Subcutaneous electrocardiogram S ICD Subcutaneous implantable cardioverter defibrillator SVT Supraventricular tachycardia TENS Transcutaneous electrical nerve stimulation VF Ventricular fibrillation VT Ventricular tachycardia Table of Contents Description Related Information Intended Audience Indications for Use Contraindications Warnings General Handling Implantation Pos
49. he additional counterclockwise torque of this wrench may cause these setscrews to become stuck if tightened against the stop Using the EMBLEM S ICD Pulse Generator Items Included in Package The device has been sterilized with ethylene oxide gas and is packaged in a sterile container that is suitable for use in the operating field Store in a clean dry area Each package contains the following One EMBLEM S ICD pulse generator Model A209 One bidirectional torque wrench One EMBLEM S ICD pulse generator Model A209 user s manual Note Accessories e g wrenches are intended for one time use only They should not be resterilized or reused 55 Implanting the S ICD System This section presents the information necessary for implanting and testing the S ICD System including implanting the EMBLEM S ICD pulse generator the device implanting the EMBLEM S ICD subcutaneous electrode the electrode using the EMBLEM S ICD subcutaneous electrode insertion tool the EIT Setting up and testing the device using the EMBLEM S ICD programmer the programmer Warning Al Boston Scientific 5 ICD implantable components are designed for use with the Boston Scientific or Cameron Health S ICD System only Connection of any S ICD System components to a non compatible component will result in failure to deliver life saving defibrillation therapy The S ICD System is designed to be positioned using anatomical landm
50. he energy consumption in the longevity table is based upon theoretical electrical principles and verified via bench testing only Full energy charges result from capacitor reformations non sustained episodes and delivered shocks Caution Battery depletion will eventually cause the S ICD Pulse Generator to stop functioning Defibrillation and excessive numbers of charging cycles shorten the battery longevity Longevity is also affected in the following circumstances A decrease in charging frequency may increase longevity An additional maximum energy shock reduces longevity by approximately 29 days 73 One hour of additional telemetry reduces longevity by approximately 14 days Five patient initiated LATITUDE Communicator interrogations per week for a year reduces longevity by approximately 11 days An additional 6 months in Shelf mode prior to implant will reduce longevity by 103 days Device longevity may also be affected by tolerances of electronic components variations in programmed parameters and variations in usage as a result of patient condition Refer to the Device Status screen on the programmer and printed reports for an estimate of remaining battery capacity specific to the implanted device Specifications Specifications provided at 37 C 3 C and assume a 75 Ohm 1 load unless noted otherwise X ray Identifier The pulse generator has an identifier that is visible on x ray film or under fluorosco
51. ia 6 1 9 4 1 2 3 0 9 1 0 3 1 0 3 1 0 3 1 0 3 23 Safety and Effectiveness Results Safety Results The 180 day Type complication free rate was assessed in all patients with an attempted S ICD System implant N 321 for the primary safety endpoint A Type complication was defined as any clinical event caused by the S ICD System that required invasive intervention The Type complication free rate at 180 days was 99 0 with a lower 95 confidence bound of 97 9 These results meet the primary safety endpoint performance goal of 79 and demonstrate the safety of the S ICD System Details of the Kaplan Meier analysis are shown in Figure 2 and Table 5 SMS W iii i 0 94 08 4 180 Day Performance Goal 79 S 074 8 0 64 pi 0 54 E 2 04 E E g 034 2 2 0 2 014 K M Estimate a 95 LCB 2 Sided Peto Method 0 04 T T T T T T 0 30 60 90 120 150 180 Post op Days Figure 2 Primary Safety Endpoint Kaplan Meier Analysis 24 Table 5 Kaplan Meier Estimates for Primary Safety Endpoint Start of Interval Statistic Days from Implant 30 90 180 Number Remaining at Risk 311 308 274 Cumulative Patients Censored 10 44 Cumulative Patients with Events KM Estimate of Patients Free from Event 95 Lower Confidence Bound Clinical Events A Clinical Event is defined
52. ill be permanently programmed e g DOO for most dual chamber modes and VOO for single chamber modes 1 Complete the S ICD System setup procedure 2 Observe the S ECG for any pacing artifacts If any pacing artifacts are present and larger in amplitude than the R wave use of the S ICD System is not recommended 3 Induce the tachyarrhythmia and observe the S ECG markers to determine appropriate detection and delivery of therapy 83 4 Ifinappropriate sensing is observed as a result of the device sensing the pacing artifact reduce the pacemakers pacing output and retest In addition pacemaker operation may be affected by the S ICD System therapy delivery This could alter the pacemaker s programmed settings or damage the pacemaker In this situation most pacemakers will conduct a memory check to determine if the parameters for safe operation were affected Further interrogation will determine if programmed pacemaker parameters are altered Refer to the manufacturer s pacemaker manual for implantation and explantation considerations Warranty Information A limited warranty certificate for the pulse generator is available at www bostonscientific com For a copy contact Boston Scientific using the information on the back cover 84 Boston Scientific 2015 Boston Scientific Corporation or its affiliates All rights reserved Boston Scientific 4100 Hamline Avenue North St Paul MN 55112 5798 USA www bostonscientific c
53. indicated for use with the S ICD System Warnings General Labeling knowledge Read this manual thoroughly before using the S ICD System to avoid damage to the pulse generator and or subcutaneous electrode Such damage can result in patient injury or death 150 1 is a non standard connector unique to the S ICD System Handling For single patient use only Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and or lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Component Compatibility All Boston Scientific S ICD implantable components are designed for use with the Boston Scientific or Cameron Health S ICD System only Connection of any S ICD System components to a non compatible component will result in failure to deliver life saving defibrillation therapy Backup defibrillation protection Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia
54. inued chronic performance of the S ICD System during appropriate device detected episodes of VT or VF To observe the continued chronic performance of the S ICD System during induced episodes of VT or VF at least 150 days post implant Accountability of PMA Cohort Of 330 patients enrolled in PMA study 321 underwent an implant procedure of whom 314 were implanted with the S ICD System There were 293 patients still active at the time of database lock on February 14 2012 The mean follow up duration for all patients implanted was 330 days with a range of 17 to 715 days Cumulative time of follow up for all implanted patients was 3 410 months The disposition of all study participants is summarized in Figure 1 below Enrolled n 330 Implant Attempt n 321 Withdrawn Prior to Implant Procedure n 9 Implanted n 314 Not Implanted n 7 All 7 Withdrawn Discontinued n 21 11 Explanted 2 Withdrawn 8 Deaths Figure 1 Summary of Patient Status as of 14 February 2012 The primary safety endpoint analysis cohort includes all patients who underwent an implant attempt for the S ICD System N 321 The primary effectiveness endpoint cohort includes all patients undergoing an implant attempt with complete acute induced VF conversion tests N 304 A total of 17 patients did not complete acute induced VF conversion testing as defined in the protocol Seven of the 17 patients were ul
55. ion LVEF less than 35 due to prior MI who are at least 88 27 4 40 days post MI and are in NYHA functional Class II or III Non ischemic DCM and an LVEF less than or equal to 35 and is in NYHA functional 76 23 7 Class Il or Ill Survivor of cardiac arrest due to VF or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible 40 12 5 causes Hypertrophic Cardiomyopathy with risk for SCD 28 8 7 Structural heart disease and spontaneous sustained VT whether hemodynamically 7 5 4 7 stable or unstable Left Ventricular LV dysfunction due to prior MI and is at least 40 days post MI has 13 4 0 an LVEF less than 30 and is in NYHA functional Class Cardiomyopathy with risk for SCD 13 4 0 Long QT syndrome with risk of SCD 12 3 7 Brugada syndrome with risk for SCD 0 3 1 Syncope of undetermined origin with clinically relevant hemodynamically significant 7 2 2 Indication Details N 321 Patients n Familial cardiomyopathy associated with SCD Cardiac sarcoidosis or Chagas disease Arrhythmogenic Right Ventricular Dysplasia Cardiomyopathy ARVD C with risk for SCD Nonsustained VT due to prior MI LVEF less than 40 and inducible VF or sustained neces 2 0 6 VT at electrophysiological study LV noncompaction Catecholaminergic polymorphic VT Sustained VT and normal or near normal ventricular function Symptomatic ventricular arrhythm
56. ion of diathermy therapy with an implanted S ICD pulse generator or electrode can damage the pulse generator and cause patient injury Magnetic Resonance Imaging MRI exposure Do not expose a patient to MRI scanning Strong magnetic fields may damage the pulse generator and or subcutaneous electrode possibly resulting in injury to or death of the patient Protected environments Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device including areas protected by a warning notice that prevents entry by patients who have a pulse generator Sensitivity settings and EMI The pulse generator may be more susceptible to low frequency electromagnetic interference at induced signals greater than 80 uV Oversensing of noise due to this increased susceptibility could lead to inappropriate shocks and should be taken into consideration when determining the follow up schedule for patients exposed to low frequency electromagnetic interference The most common source of electromagnetic interference in this frequency range is the power system for some European trains which operate at 16 6 Hz Particular attention should be given to patients with occupational exposure to these types of systems Precautions Clinical Considerations e Longevity Battery depletion will eventually cause the S ICD pulse generator to stop functioning Defibrillation and excessive numbers
57. isode is declared up to a maximum of five extensions Thus after an untreated episode the requirement to start capacitor charging becomes more stringent The Smart Charge extension value can be reset to its nominal value zero extensions using the programmer The Smart Charge feature cannot be disabled though it is not used for the second and later shocks that occur during any given episode 45 Redetection A blanking period is enabled following delivery of a high voltage shock After delivery of the first shock up to four additional shocks will be delivered if the episode does not terminate Rhythm analysis for delivering shocks 2 5 generally follows the detection steps described above with the following exceptions 1 Following the first shock delivery the X Y criterion is modified to require 14 treatable intervals in the last 24 14 24 rather than 18 2 The Persistence Factor is always set to two intervals i e not modified by the Smart Charge feature Shock Waveform and Polarity The shock waveform is biphasic with a fixed tilt of 50 The shock is delivered synchronously unless a 1000 ms time out expires without an event being detected for synchronization at which time the shock is delivered in an asynchronous manner The device is designed to automatically select the appropriate polarity for therapy Both standard and reversed polarity shocks are available If a shock fails to convert the arrhythmia and subsequent shocks a
58. llowing any surgery or medical procedure with the potential to affect pulse generator function you should perform a thorough follow up which may include the following Interrogating the pulse generator with a programmer Reviewing stored events fault codes and real time S ECGs prior to saving all patient data Testing the subcutaneous electrode impedance Verifying battery status Printing any desired reports Verifying the appropriate final programming prior to allowing the patient to leave the clinic vw vw VY VY v v Ending session Potential Adverse Events Potential adverse events related to implantation of the S ICD System may include but are not limited to the following Acceleration induction of atrial or ventricular arrhythmia Adverse reaction to induction testing Allergic adverse reaction to system or medication Bleeding Conductor fracture Cyst formation Death Delayed therapy delivery Discomfort or prolonged healing of incision Electrode deformation and or breakage Electrode insulation failure Erosion extrusion Failure to deliver therapy Fever Hematoma seroma Hemothorax Improper electrode connection to the device Inability to communicate with the device Inability to defibrillate or pace Inappropriate post shock pacing Inappropriate shock delivery Infection Keloid formation Migration or dislodgement Muscle nerve stimulation Nerve damage Pneumothorax Post shock post pace discomfort P
59. m 46 Auto Capacitor Reformation The device automatically performs a full energy 80 J capacitor reformation when taken out of Shelf mode and every four months until the device reaches Elective Replacement ERI The energy output and reformation time interval are non programmable The Auto Capacitor Reformation interval is reset after any 80 J capacitor charge is delivered or aborted Internal Warning System Beeper Control The device has an internal warning system beeper that emits an audible tone to alert the patient to certain device conditions that require prompt consultation with the physician These conditions include Elective Replacement ERI and End of Life EOL indicators see page 48 Electrode impedance out of range Prolonged charge times Failed Device Integrity Check Irregular battery depletion This internal warning system is automatically activated at time of implant Once triggered the beeper sounds for 16 seconds every nine hours until the trigger condition has been resolved If the triggering condition reoccurs then the tones will once again alert the patient to consult the physician The beeper can be disabled via the programmer once ERI is reached Caution Patients should be advised to contact their physician immediately whenever they hear beeping tones coming from their device Note The beeper may be activated for demonstration purposes in the clinic by applying a magnet over the device
60. med out of Shelf mode before being programmed to Therapy On Therapy Off Mode The Therapy Off mode disables automatic therapy delivery while still allowing manual control of shock delivery Programmable parameters may be viewed and adjusted via the programmer Also the subcutaneous electrogram S ECG may be displayed or printed 4 The device automatically defaults to Therapy Off when taken out of Shelf mode Note Manual and rescue shock therapy are available when the device is set to Therapy On or Therapy Off mode but only after the initial Setup process is complete Refer to Setting up the EMBLEM S ICD Pulse Generator on page 65 Sensing Configuration and Gain Selection During the Automatic Setup process the device automatically selects an optimal sensing vector based on an analysis of cardiac signal amplitude and signal to noise ratio This analysis is performed on the three available vectors Primary Sensing from the proximal electrode ring on the subcutaneous electrode to the active surface of the device Secondary Sensing from the distal sensing electrode ring on the subcutaneous electrode to the active surface of the device Alternate Sensing from the distal sensing electrode ring to the proximal sensing electrode ring on the subcutaneous electrode The sensing vector can also be selected manually The EMBLEM S ICD Programmer User s Manual provides additional information about sensing vector selection The de
61. nal wires Replacement device Implanting a replacement device in a subcutaneous pocket that previously housed a larger device may result in pocket air entrapment migration erosion or insufficient grounding between the device and tissue Irrigating the pocket with sterile saline solution decreases the possibility of pocket air entrapment and insufficient grounding Suturing the device in place reduces the possibility of migration and erosion Telemetry wand The wand is a non sterile device Do not sterilize the wand or programmer The wand must be contained in a sterile barrier before use in the sterile field Device Programming Device communication Use only the designated programmer and software application to communicate with the S ICD pulse generator e Sensing adjustment Following any sensing parameter adjustment or any modification of the subcutaneous electrode always verify appropriate sensing Patients hear tones coming from their device Patients should be advised to contact their physician immediately whenever they hear beeping tones coming from their device Programming for supraventricular tachyarrhythmias SVTs Determine if the device and programmed parameters are appropriate for patients with SVTs because SVTs can initiate unwanted device therapy Environmental and Medical Therapy Hazards Avoid electromagnetic interference EMI Advise patients to avoid sources of EMI because EMI may cause the pulse gene
62. neous electrode connector into the port to release any trapped fluid or air Visually verify that the setscrew is sufficiently retracted to allow insertion Use the torque wrench to loosen the setscrew if necessary fully insert the subcutaneous electrode connector into the port and then tighten the setscrew onto the connector 61 62 Figure 18 Inserting the torque wrench With the torque wrench in place fully insert the subcutaneous electrode terminal into the electrode port Grip the subcutaneous electrode close to the connector and insert it straight into the connector port The electrode is fully inserted when the tip of the connector is visible beyond the connector block when viewed from the top Refer to Figure 19 for illustrations of the header connector block with no electrode inserted top panel and with the electrode fully inserted bottom panel Place pressure on the subcutaneous electrode to maintain its position and ensure that it remains fully inserted in the connector port TOP VIEW No electrode inserted Setscrew Electrode fully inserted Tip of connector Setscrew Electrode Figure 19 Position of the subcutaneous electrode connector Warning Use caution handling the subcutaneous electrode connector Do not directly contact the connector with any surgical instruments such as forceps hemostats or clamps This could damage the connector A damaged connector may result in compromised sealing integrity
63. nerator and shielding of the pulse generator The impact of ionizing radiation will also vary from one pulse generator to another and may range from no changes in function to a loss of therapy Sources of ionizing radiation vary significantly in their potential impact on an implanted pulse generator Several therapeutic radiation sources are capable of interfering with or damaging an implanted pulse generator including those used for the treatment of cancer such as radioactive cobalt linear accelerators radioactive seeds and betatrons Prior to a course of therapeutic radiation treatment the patient s radiation oncologist and cardiologist or electrophysiologist should consider all patient management options including increased follow up and device replacement Other considerations include Shield the Pulse Generator with a radiation resistant material regardless of the distance between the Pulse Generator and the radiation beam gt Determining the appropriate level of patient monitoring during treatment Evaluate pulse generator operation during and following the course of radiation treatment to exercise as much device functionality as possible Post Therapy Pulse Generator Follow Up on page 13 The extent timing and frequency of this evaluation relative to the radiation therapy regimen are dependent upon current patient health and therefore should be determined by the attending cardiologist or electrophysiologist Pulse gene
64. non evaluable test did not complete testing in the opposite polarity after a failed 65 shock as required by the protocol All three were converted with a subsequent 80J S ICD System shock 34 The rate of successful conversion by a sub maximal 65J S ICD System shock was 72 75 96 0 All 3 75 4 0 patients who failed to convert with a sub maximal 65J S ICD System shock in either polarity were successfully converted with a subsequent higher energy S ICD System shock Subgroup Analyses Stepwise logistic regression models backward elimination with a threshold p value of 0 20 were used to evaluate basic demographic characteristics age gender African American race and baseline device programming dual zone programming at hospital discharge for statistical associations between with following safety related outcomes All Inappropriate shocks n 41 Inappropriate shocks for oversensing n 25 Inappropriate shocks for SVT n 16 Discomfort n 22 System and Superficial Incision Infection n 18 Type I Ill Complications n 35 Age Age was a significant predictor for inappropriate shocks Patients who experienced inappropriate shocks were younger with a mean age of 47 compared to a mean age of 53 for patients who did not receive any inappropriate shocks Gender Female gender was significantly associated with a higher risk for device or procedure related discomfort Although the numbers are very small it is not
65. ntact information Device and subcutaneous electrode identification information model and serial numbers and implant date Patient Notes displayed upon connection to the device 51 S ICD System Magnet Use The Boston Scientific magnet Model 6860 the magnet is a non sterile accessory that may be used to temporarily inhibit the delivery of therapy from the device if necessary The Cameron Health magnet Model 4520 may be used interchangeably with the Boston Scientific magnet for this purpose Note When long duration therapy suspension is desired it is recommended to modify pulse generator behavior with the programmer rather than the magnet whenever possible To suspend therapy using a magnet 1 APPLY the magnet over the device header or over the lower edge of the device as illustrated in Figure 11 2 LISTEN for beeping tones use a stethoscope if necessary Therapy is not suspended until beeping tones are heard If no beeping is heard try other positions within the target zones illustrated in Figure 12 until beeping tones are heard Maintain the magnet in each tested position for one second it takes approximately one second for the pulse generator to respond to the magnet 3 HOLD the magnet in place to keep therapy suspended Beeping will continue for 60 seconds while the magnet is held in place After 60 seconds beeping stops but therapy continues to be inhibited unless the magnet has been moved Note fit is necessary
66. nts resulted in 81 total device episodes 40 of which were VF and stored in S ICD System memory with the remaining 41 episodes not stored due to memory capacity limitations Three 3 storms were ultimately converted by the S ICD System and 1 was ultimately converted with an external defibrillation shock Table 12 Of the 40 storm episodes with recorded data 53 total shocks successful conversion following at least one shock from either shock polarity shock 1 amp 2 was 92 5 33 Table 11 Conversion Effectiveness of Discrete Device Episodes non Storm Patients with discrete episodes N 21 Discrete device episodes N 38 Episode Episode Converted by Converted by 15t Shock Any Shock Device Episodes MVT 21 95 5 21 95 5 PVT VF 14 87 5 16 100 0 Total 35 92 1 37 97 4 Table 12 Conversion of VT VF Storms Patients with VT VF Storms N 2 Storm events N 4 Stored Device episodes N 40 VT VF Device Final Storm Storms Episodes Conversion Method S ICD 3 75 Patients External 1 25 Spontaneous Conversion 0 0 Chronic Conversion Substudy The chronic performance of the S ICD System was assessed by the proportion of patients with successful conversion of induced VT VF 150 days post implant in all implanted patients who provided informed consent for this testing N 78 Three 3 patients were excluded from the analysis because they met the pre specified definition of a
67. o the patient has the potential to interfere with pulse generator function Medical therapies treatments and diagnostic tests that use conducted electrical current e g TENS electrocautery electrolysis thermolysis electrodiagnostic testing electromyography or nerve conduction studies may interfere with or damage the pulse generator Program the device to Therapy Off mode prior to the treatment and monitor device performance during the treatment After the treatment verify pulse generator function Post Therapy Pulse Generator Follow Up on page 13 Implanted medical devices with the potential to generate electromagnetic interference EMI Electro mechanical medical devices that are implanted near the S ICD System for example implantable insulin pumps drug pumps or ventricular assist devices have the potential to generate EMI and could interfere with S ICD System function Consider and or test for potential effects of EMI if such devices are implanted near the S ICD System Implanted medical devices with the potential to generate magnetic fields Some implanted medical devices including ventricular assist devices and drug or insulin pumps contain permanent magnets and motors which may create strong magnetic fields greater than 10 gauss or 1 mTesla Magnetic fields may suspend arrhythmia detection and therapy delivery if implanted in proximity to the S ICD Verify that S ICD arrhythmia detection and therapy delivery functions appropria
68. ock Zone is shown below Figure 7 SHOCK Zone Rate Only Conditional Shock Zone Discrimination Active Figure 7 Shock Zone Rate Detection Diagram 43 The device declares a Tachycardia when the 4RR average enters either therapy zone Once a Tachycardia is declared the 4RR average must become longer in ms than the lowest rate zone plus 40 ms for 24 cycles for the device to consider the episode to have ended In the Shock Zone treatable arrhythmias are determined by rate alone Analysis in the Conditional Shock Zone In contrast rate and morphology are analyzed in the Conditional Shock Zone The Conditional Shock Zone is designed to discriminate between treatable and other high rate events such as atrial fibrillation sinus tachycardia and other supraventricular tachycardias A normal sinus rhythm template NSR Template is formed during device initialization This NSR template is used during analysis in the Conditional Shock Zone to identify treatable arrhythmias In addition to morphology comparison with the NSR template other morphologic analysis is used to identify polymorphic rhythms Morphology and QRS width are used to identify monomorphic arrhythmias such as ventricular tachycardia If the Conditional Shock Zone is enabled then an arrhythmia is found to be treatable according to the decision tree shown below Figure 8 Certification Phase ompare Current Certified Event and Previous
69. of implant and the remaining four 4 occurred after 360 days post implant 26 Table 7 Type I Clinical Events All patients with an implant attempt N 321 Clinical Event Discomfort Complications Events Patients Observations Patients Patients 8 7 22 1 1GA Inability to Communicate with the Device Inappropriate Shock Oversensing Numbness at Device Site Premature Battery Depletion Subcutaneous Emphysema All Type I Clinical Events 11 3 4 30 9 3 39 12 1 27 Table 8 Type II Clinical Events All patients with an implant attempt N 321 Clinical Event Electrode Movement Inappropriate Electrode Connection to the Device Sub optimal Electrode Position All Type Il Clinical Events 28 Complications Patients Observations Patients Patients Table 9 Type Il Clinical Events All patients with an implant attempt N 321 Complications Observations Clinical Event Events Patients Events Patients Events Patients Acute Hypoxic Respiratory 0 0 0 0 1 1 0 3 1 1 0 3 Failure Adverse Reaction to 3 3 0 9 5 5 1 6 8 8 2 5 Medication Atrial Fibrillation 0 0 0 0 14 14 4 4 14 14 4 4 Flutter Bleeding 0 0 0 0 1 1 0 3 1 1 0 3 Discomfort 1 1 0 3 12 12 3 7 13 12 3 7 Electrode Mavenient 1 1 0 3 0 0 0 0 1 1 0 3 Fever 0 0 0 0 3 3 0 9 3 3 0
70. om 1 800 CARDIAC 227 3422 1 651 582 4000 359278 002 EN US 2015 02
71. py This identifier provides noninvasive confirmation of the manufacturer and consists of the following The letters BSC to identify Boston Scientific as the manufacturer The number 507 to identify the Model 2877 S ICD programmer software application needed to communicate with the pulse generator The x ray identifier is located in the pulse generator case just below the header Figure 23 and is read vertically Figure 23 Location of the x ray ID 1 x ray identifier location 2 header 3 pulse generator case 74 Table 16 Mechanical Specifications Dimensions Model WxHxD Mass g Volume cm palit finn yp SQ 1 S ICD A209 83 1 x 69 1 x 12 7 130 59 5 connector non standard The EMBLEM S ICD pulse generator is compatible with both the Cameron Health Model 3010 subcutaneous electrode and the EMBLEM S ICD subcutaneous electrode The pulse generator has a case electrode surface area of 111 0 cm2 Material Specfications ase hermetically sealed titanium coated with titanium nitride Header implantation grade polymer Power Supply lithium manganese dioxide cell Boston Scientific 400530 75 76 Table 17 Programmable Parameters Nominal Parameter Programmable Values as shipped Shock Zone 170 bpm 250 bpm steps of 10 bpm 220 bpm Conditional Shock Off 170 bpm 240 bpm 200 bom Zone If On at least 10 bpm less than Shock Zone p S ICD Pulse G nerator Mod Shelf Therapy On Thera
72. py Off Shelf Post shock Pacing On Off off Primary Proximal electrode ring to device Sensing Secondary Distal electrode ring to device Primary Configuration Alternate Distal electrode ring to proximal electrode ring p x1 4mV Max Sensing Range x1 x2 2 mV Manual Shock 10 80 J in steps of 5 J 80 Smart Charge Resets to nominal 0 extensions Standard Phase 1 Coil Polarity Standard Reverse Phase 1 Coil Table 18 Non Programmable Parameters Shock Therapy Parameter Value SHOCK THERAPY Delivered Energy Peak Shock Voltage 80 J Shock Tilt Waveform Type Maximum Number of Shocks per episode Charge Time to 80 J BOL ERI Sync Time Out Shock Sync Delay Post Shock Blanking Period 80J 5 shocks lt 10sec lt 15 ee P i 1600 ms 4 Charge time is one portion of the overall time to therapy BOL refers to beginning of life b Under typical conditions 77 Table 19 Non Programmable Parameters Post Shock Pacing Parameter Value POST SHOCK PACING Rate 50 ppm Pacing Output 200mA Pulse Width exch phase 16 ii Waveform Bias Polarity first phase Standard Phase Cll Mode Inhibited Pacing Duration see Post Pace Blanking Period 750 ms first pace pulse AAE nog 550 ms subsequent pace pulses Runaway Protection 120 ppm 78 Table 20 Non Programmable Parameters Detection Rhythm Discrimination Fibrillation Induction Sensin
73. r lead to device failure which in turn may result in patient injury illness or death Reuse reprocessing or resterilization may also create a risk of contamination of the device and or cause patient infection or cross infection including but not limited to the transmission of infectious disease s from one patient to another Contamination of the device may lead to injury illness or death of the patient Contact Boston Scientific When a product is removed from service Inthe event of patient death regardless of cause along with an autopsy report if performed Due to other observations or complications Note Disposal of explanted pulse generators and or subcutaneous electrodes is subject to applicable laws and regulations For a Returned Product Kit contact Boston Scientific using the information on the back cover Caution Be sure that the pulse generator is removed before cremation Cremation and incineration temperatures might cause the pulse generator to explode Caution Before explanting cleaning or shipping the device complete the following actions to prevent unwanted shocks overwriting of important therapy history data and audible tones Program the pulse generator to Therapy Off mode fERI or EOL has been reached disable the beeper Clean and disinfect the device using standard biohazard handling techniques Consider the following items when explanting and returning the pulse generator and or subcut
74. rator diagnostics are performed automatically once per hour so pulse generator evaluation should not be concluded until pulse generator diagnostics have been updated and reviewed at least one hour after radiation exposure The effects of radiation exposure on the implanted pulse generator may remain undetected until some time following exposure For this reason continue to monitor pulse generator function closely and use caution when programming a feature in the weeks or months following radiation therapy Electrocautery and Radio Frequency RF Ablation Electrocautery and RF ablation may induce ventricular arrhythmias and or fibrillation and may cause inappropriate shocks and inhibition of post shock pacing Additionally exercise caution when performing any other type of cardiac ablation procedure in patients with implanted devices If electrocautery or RF ablation is medically necessary observe the following to minimize risk to the patient and device gt Program the pulse generator to Therapy Off mode Have external defibrillation equipment available Avoid direct contact between the electrocautery equipment or ablation catheters and the pulse generator and subcutaneous electrode gt Keep the path of the electrical current as far away as possible from the pulse generator and subcutaneous electrode IRF ablation and or electrocautery is performed on tissue near the device or subcutaneous electrode verify pulse generator func
75. rator to deliver inappropriate therapy or inhibit appropriate therapy Moving away from the source of the EMI or turning off the source usually allows the pulse generator to return to normal operation Examples of potential EMI sources are ww VY VY YY YY v Electrical power sources arc welding or resistance welding equipment and robotic jacks High voltage power distribution lines Electrical smelting furnaces Large RF transmitters such as radar Radio transmitters including those used to control toys Electronic surveillance antitheft devices An alternator on a car that is running Medical treatments and diagnostic tests in which an electrical current is passed through the body such as TENS electrocautery electrolysis thermolysis electrodiagnostic testing electromyography or nerve conduction studies Any externally applied device that uses an automatic lead detection alarm system e g an EKG machine Hospital and Medical Environments External defibrillation External defibrillation or cardioversion can damage the pulse generator or subcutaneous electrode To help prevent damage to implanted system components consider the following Avoid placing a pad or paddle directly over the pulse generator or subcutaneous electrode Position the pads or paddles as far from the implanted system components as possible Set energy output of external defibrillation equipment as low as clinically acceptable Following external
76. re required polarity is automatically reversed for each successive shock The polarity of the successful shock is then retained as the starting polarity for future episodes Polarity can also be selected during the Induction and Manual Shock process to facilitate device based testing Post Shock Bradycardia Pacing Therapy The device provides optional post shock on demand bradycardia pacing therapy When enabled via the programmer bradycardia pacing occurs at a non programmable rate of 50 bpm for up to 30 seconds The pacing output is fixed at 200 mA and uses a 15 ms biphasic waveform Pacing is inhibited if the intrinsic rate is greater than 50 bpm In addition post shock pacing is terminated if a tachyarrhythmia is detected or a magnet is placed over the device during the post shock pacing period Manual and Rescue Shock Delivery Upon programmer command the device can deliver manual and rescue shocks Manual shocks are programmable from 10 to 80 J delivered energy in 5 J steps Rescue shocks are non programmable delivering the maximum output of 80 J Note A rescue shock that is commanded when the magnet is already in place will be delivered but if the magnet is applied after the rescue shock is commanded the shock will be aborted Refer to the S ICD System Magnet Use section for complete information Additional Features of the S ICD System This section presents descriptions of several additional features available in the S ICD Syste
77. remature battery depletion Random component failures Stroke Subcutaneous emphysema Surgical revision or replacement of the system Syncope Tissue redness irritation numbness or necrosis If any adverse events occur invasive corrective action and or S ICD System modification or removal may be required Patients who receive an S ICD System may develop psychological disorders that include but are not limited to the following Depression anxiety Fear of device malfunction Fear of shocks Phantom shocks Clinical Summary The following clinical summary is applicable to the EMBLEM S ICD System The study was conducted using the first generation version of the S ICD System The EMBLEM System provides the same therapies for the same indications as the system used in the study S ICD System Clinical Investigation The S ICD System Clinical Investigation was a single arm prospective non randomized multicenter clinical study conducted in patients age 18 or older who had an existing transvenous ICD or who met guideline indications for ICD therapy and had an appropriate pre operative ECG Patients with documented spontaneous and frequently recurring ventricular tachycardia VT that was reliably terminated with anti tachycardia pacing were excluded unless they were not a candidate for a transvenous ICD system The study was conducted at 33 participating centers 28 centers in the United States 2 centers in The Ne
78. rmation Patient management and follow up are at the discretion of the patient s physician but are recommended one month after implant and at least every 3 months to monitor the condition of the patient and evaluate device function Office visits may be supplemented by remote monitoring where available Note Because the duration of the device replacement timer is three months starting when ERI is reached three month follow up frequency is particularly important to ensure timely replacement of the device if necessary Caution Successful VF or VT conversion during arrhythmia conversion testing is no assurance that conversion will occur post operatively Be aware that changes in the patient s condition drug regimen and other factors may change the DFT which may result in nonconversion of the arrhythmia post operatively Verify with a conversion test that the patient s tachyarrhythmias can be detected and terminated by the pulse generator system if the patient s status has changed or parameters have been reprogrammed 69 Explantation Note Return all explanted pulse generators and subcutaneous electrodes to Boston Scientific Examination of explanted pulse generators and subcutaneous electrodes can provide information for continued improvement in system reliability and warranty considerations Warning Do not reuse reprocess or resterilize Reuse reprocessing or resterilization may compromise the structural integrity of the device and o
79. rofiles are designed to ensure appropriate device performance by identifying signal characteristics that may lead to unsatisfactory detection outcomes for a patient before implant The patient screening process is completed in three steps 1 Collecting the surface ECG 2 Evaluating the surface ECG and 3 Determining an acceptable sense vector The patient screening tool can be obtained from any Boston Scientific representative or by contacting Boston Scientific using the information on the back cover 400 300 200 150 10090 80 70 60 HEART RATE 25 mm sec 2 x RR FROM REFERENCE ARROW Boston Scientific 14 cm GUIDE Note For screening ECG electrodes should not extend beyond 14 cm arrows Figure 3 Patient Screening Tool Each colored profile is assigned a letter A B C D E F for ease of reference Collecting the Surface ECG 1 In order to perform the patient screening process a surface equivalent of the subcutaneous sensing vectors must be obtained It is important to collect the surface ECG in the location that represents the intended position of the implanted S ICD System When placing the S ICD System in the typical implant location the surface ECG electrode should be positioned as described below Figure 4 If a non standard S ICD System subcutaneous electrode or pulse generator placement is desired the surface ECG electrode locations should be modified accordingly ECG Electrode LL should be
80. t kink crush stretch or otherwise damage any component of the S ICD System Impairment to the S ICD System may result in an inappropriate shock or failure to deliver therapy to the patient Handling the subcutaneous electrode Use caution handling the subcutaneous electrode connector Do not directly contact the connector with any surgical instruments such as forceps hemostats or Implantation e Post Implant clamps This could damage the connector A damaged connector may result in compromised sealing integrity possibly leading to compromised sensing loss of therapy or inappropriate therapy System dislodgement Use appropriate anchoring techniques as described in the implant procedure to prevent S ICD System dislodgement and or migration Dislodgement and or migration of the S ICD System may result in an inappropriate shock or failure to deliver therapy to the patient Magnet Response Use caution when placing a magnet over the S ICD pulse generator because it suspends arrhythmia detection and therapy response Removing the magnet resumes arrhythmia detection and therapy response Magnet response with deep implant placement In patients with a deep implant placement greater distance between the magnet and the pulse generator magnet application may fail to elicit the magnet response In this case the magnet cannot be used to inhibit therapy Diathermy Do not expose a patient with an implanted S ICD System to diathermy The interact
81. t Implant Precautions Clinical Considerations Sterilization and Storage Implantation Device Programming Environmental and Medical Therapy Hazards Hospital and Medical Environments Home and Occupational Environments Follow up Testing Explant and Disposal Supplemental Precautionary Information Potential Adverse Events Clinical Summary S ICD System Clinical Investigation Methods Primary Objectives Additional Objectives Accountability of PMA Cohort Study Population Demographics and Baseline Parameters Dost FBP BPWWYrN RS BS RS eS KS ss RWWwWrY OC Ww poe ee ee ee ee ONDNDAAHUN WM Safety and Effectiveness Results Effectiveness Results Subgroup Analyses Conclusion Patient Screening Collecting the Surface ECG Evaluating the Surface ECG Determining an Acceptable Sense Vector Operation General Modes of Operation Shelf Mode Therapy On Mode Therapy Off Mode Sensing Configuration and Gain Selection Sensing and Tachyarrhythmia Detection Detection Phase Certification Phase Decision Phase Therapy Zones Analysis in the Conditional Shock Zone Charge Confirmation Therapy Delivery Smart Charge Redetection Shock Waveform and Polarity Post Shock Bradycardia Pacing Therapy Manual and Rescue Shock Delivery Additional Features of the S ICD System Auto Capacitor Reformation Internal Warning System Beeper Control 24 32 35 36 37 37 38 40 4 4 4 4 4 4 42 42 42 43 43 43 44 45 45 45 46 4
82. tely when the S ICD System is implanted concomitantly with such a device Transcutaneous Electrical Nerve Stimulation TENS TENS involves passing electrical current through the body and may interfere with pulse generator function If TENS is medically necessary evaluate the TENS therapy settings for compatibility with the pulse generator The following guidelines may reduce the likelihood of interaction Place the TENS electrodes as close together and as far away from the pulse generator and subcutaneous electrode as possible Use the lowest clinically appropriate TENS energy output gt Consider cardiac monitoring during TENS use Additional steps can be taken to help reduce interference during in clinic use of TENS If interference is suspected during in clinic use turn off the TENS unit Do not change TENS settings until you have verified that the new settings do not interfere with pulse generator function If TENS is medically necessary outside the clinical setting at home use provide patients with the following instructions gt Do not change the TENS settings or electrode positions unless instructed to do so gt End each TENS session by turning off the unit before removing the electrodes Ifthe patient receives a shock during TENS use they should turn off the TENS unit and contact their physician Follow these steps to use the programmer to evaluate pulse generator function during TENS use 1 Program the
83. ter distance between the magnet and the pulse generator magnet application may fail to elicit the magnet response In this case the magnet cannot be used to inhibit therapy Magnet Response and Pulse Generator Mode The effect of the magnet on the pulse generator varies depending on the Mode the pulse generator is programmed to Shelf Therapy On or Therapy Off as shown in Table 14 Table 14 Magnet Response Pulse Generator Mode Magnet Response Shelf Mode Asingle beep sounds when the magnet is detected Arrhythmia detection and therapy response are suspended until the magnet is removed The beeper sounds with each detected QRS complex for 60 seconds or until the magnet is removed whichever occurs first Therapy On Programmer commanded rescue shocks and manual shocks are aborted if the magnet is applied after the shock is commanded Post shock pacing is terminated Arrhythmia induction testing is prohibited The beeper sounds with each detected QRS complex for 60 seconds or until the magnet is removed whichever occurs first Therapy Off Programmer commanded rescue shocks and manual shocks are aborted if the magnet is applied after the shock is commanded Post shock pacing is terminated Programmer commanded rescue shocks and manual shocks are delivered if they are commanded with the magnet already in place Note fthe magnet is applied during an episode the episode will not be stored in the device memory Note
84. ter operates in the 402 405 MHz band using FSK modulation with radiated power conforming to the applicable 25 pW limit The purpose of the transmitter is to communicate with the S ICD System programmer to transfer data and to receive and respond to programming commands Caution Changes or modifications not expressly approved by Boston Scientific could void the user s authority to operate the equipment FCC ID ESCCRMA20914 Additional Information Product Reliability It is Boston Scientific s intent to provide implantable devices of high quality and reliability However these devices may exhibit malfunctions that may result in lost or compromised ability to deliver therapy These malfunctions may include the following Premature battery depletion Sensing or pacing issues Inability to shock Error codes e Loss of telemetry Refer to Boston Scientific s CRM Product Performance Report on www bostonscientific com for more information about device performance including the types and rates of malfunctions that these devices have experienced historically While historical data may not be predictive of future device performance such data can provide important context for understanding the overall reliability of these types of products 72 Sometimes device malfunctions result in the issuance of product advisories Boston Scientific determines the need to issue product advisories based on the estimated malfunction rate and the
85. therlands 2 centers in New Zealand and 1 center in The United Kingdom A total of 330 patients were enrolled in the study 321 underwent an implant procedure and 314 were implanted with the S ICD System The mean follow up duration for all patients implanted was 330 days with a range of 17 to 715 days Cumulative time of follow up for all implanted patients was 3 410 months 15 Methods Clinical data were collected at the time of enrollment implant hospital discharge follow up visits during system revisions and upon notification of clinical events study exit or protocol deviations All patients were scheduled to return for follow up examinations after the implant procedure and predischarge follow up at 30 90 and 180 days post implant and semi annually thereafter Data were collected via case report forms and programmer printouts All centers followed the same Clinical Investigational Plan and methods to collect data Primary Objectives The primary objectives of the study were To confirm safety of the S ICD System by demonstrating that the S ICD System complication free rate at 180 days post implant meets or exceeds the performance goal of 79 with at least 95 confidence To confirm effectiveness of the S ICD System by demonstrating that the induced VF conversion rate meets or exceeds the performance goal of 88 with at least 95 confidence Additional Objectives Additional objectives of the study were To observe the cont
86. timately not implanted due to difficulty converting VF at 65J Ten of the 17 patients did not complete the protocol defined testing criteria but were implanted with the S ICD System Of these 10 patients 6 patients experienced difficulty inducing VF 3 patients had difficulty converting VF at 65 and 1 patient with a persistent LV thrombus was not tested Study Population Demographics and Baseline Parameters The demographics and baseline characteristics of the study population are shown in Table 2 and Table 3 respectively Cardiovascular history included congestive heart failure 61 4 hypertension 58 3 and myocardial infarction 41 4 All patients met ICD indications as described in Table 4 Primary prevention ICD indications represented 79 4 of the cohort Additionally the study population included patients indicated for implantation due to hypertrophic cardiomyopathy 8 7 long OT syndrome 3 7 and Brugada syndrome 3 1 Table 2 Subject demographics Demographic Statistic Category Mean SD Median 51 9 15 5 53 8 Age years Range 18 5 85 2 Gender n Male 238 74 1 Female 83 25 9 Demographic Statistic Category White or Caucasian Black or African American Hispanic or Latino Asian Asian Indian Maori Pacific Islander 208 64 8 76 23 7 23 7 2 6 1 9 3 0 9 3 0 9 2 0 6 Height cm Mean SD Median Range 174 3 10 2 175 0 142 2
87. tion Post Therapy Pulse Generator Follow Up on page 13 For electrocautery use a bipolar electrocautery system where possible and use short intermittent and irregular bursts at the lowest feasible energy levels When the procedure is finished return the pulse generator to Therapy On mode Lithotripsy Extracorporeal shock wave lithotripsy ESWL may cause electromagnetic interference with or damage to the pulse generator If ESWL is medically necessary consider the following to minimize the potential for encountering interaction Avoid focusing the lithotripsy beam near the pulse generator implant site gt Program the pulse generator to Therapy Off mode to prevent inappropriate shocks Ultrasound energy Therapeutic ultrasound e g lithotripsy energy may damage the pulse generator If therapeutic ultrasound energy must be used avoid focusing near the pulse generator site Diagnostic ultrasound e g echocardiography is not known to be harmful to the pulse generator Radio frequency RF interference RF signals from devices that operate at frequencies near that of the pulse generator may interrupt telemetry while interrogating or programming the pulse generator This RF interference can be reduced by increasing the distance between the interfering device and the programmer and pulse generator Conducted electrical current Any medical equipment treatment therapy or diagnostic test that introduces electrical current int
88. tion of the S ICD System may result in an inappropriate shock or failure to deliver therapy to the patient Caution Do not suture directly over the subcutaneous electrode body as this may cause structural damage Use the suture sleeve to prevent subcutaneous electrode movement Caution Suture only those areas indicated in the implant instructions Note Ensure that the suture is securely fastened to fascia by gently tugging on the suture prior to tying to the suture sleeve and subcutaneous electrode At the superior incision secure the anchoring hole to the fascia using the pre placed sutures from step 6 Figure 17 Figure 17 Anchoring the distal tip of the subcutaneous electrode Note Ensure that the suture is securely fastened to fascia by gently tugging on the suture prior to tying to the subcutaneous electrode anchoring hole Gently tug the subcutaneous electrode at the superior incision to ensure the anchoring hole is secured to the fascia To dispose of the EIT return the used product to the original package then dispose in a biohazard container 15 To ensure good tissue contact with the implanted subcutaneous electrode flush the xiphoid and superior incisions with sterile saline solution and apply firm pressure along the electrode to express any residual air out through the incisions prior to closing Connecting the Subcutaneous Electrode to the Device When connecting the subcutaneous electrode to the device use only
89. to confirm therapy is still being inhibited after beeping has stopped remove and replace the magnet to reactivate the beeping tones This step can be repeated as necessary 4 REMOVE the magnet to resume normal pulse generator operation Figure 11 Starting position of the magnet for suspension of therapy 52 Figure 12 Grey shading indicates the zone within which magnet placement is most likely to suspend therapy as signaled by beeping tones Sweep the magnet vertically and horizontally across the target zone as indicated by the arrows Magnet use for patients with deep implant placement Consider the following when using the magnet on patients with deep implant placement ifthe exact location of the pulse generator is not evident the magnet may need to be tested across a broader region of the body surrounding the anticipated pulse generator location Unless beeping tones are heard therapy has not been suspended Beeping from a device with a deep implant location may be difficult to hear Use a stethoscope if necessary Correct magnet placement can only be confirmed by detection of the beeping tones Multiple magnets may be used in a stacked configuration to increase the likelihood of eliciting the beeping and associated inhibition of therapy if beeping tones cannot be detected it may be necessary to use the programmer to suspend therapy in these patients 53 Warning n patients with a deep implant placement grea
90. to elicit the beeping tones Arrhythmia Induction The device facilitates testing by providing the capability to induce a ventricular tachyarrhythmia Via the programmer the implanted system can deliver a 200 mA output at a frequency of 50 Hz The maximum length of stimulation is 10 seconds Note Induction requires that the device be programmed to Therapy On Warning Always have external defibrillation equipment and medical personnel skilled in CPR available during implant and follow up testing If not terminated in a timely fashion an induced ventricular tachyarrhythmia can result in the patient s death System Diagnostics The S ICD System automatically performs a diagnostic check at scheduled intervals 47 Subcutaneous Electrode Impedance A subcutaneous electrode integrity test is performed once a week using a sub threshold energy pulse The Summary report indicates whether the measured impedance is in range by reporting Ok for values below 400 ohms Values above 400 ohms will result in activation of the internal warning system beeping tones Note f the device is taken out of Shelf mode but not implanted the internal warning system will be activated due to the weekly automatic measurements of impedance Device beeping due to this mechanism is normal behavior In addition subcutaneous electrode impedance is measured each time a shock is delivered and the shock impedance values are stored and displayed in the episode data an
91. to the patient s specific health condition A Dive Medicine Specialist may also be consulted prior to SCUBA diving More frequent device follow up may be warranted in conjunction with HBOT or SCUBA diving Evaluate pulse generator operation following high pressure exposure Post Therapy Pulse Generator Follow Up on page 13 The extent timing and frequency of this evaluation relative to the high pressure exposure are dependent upon current patient health and should be determined by the attending cardiologist or electrophysiologist If you have additional questions or would like more detail regarding the test protocol or test results specific to HBOT or SCUBA diving contact Boston Scientific using the information on the back cover Follow up Testing Low shock impedance A reported shock impedance value of less than 25 ohms from a delivered shock could indicate a problem with the device The delivered shock may have been compromised and or any future therapy from the device may be compromised If a reported impedance value of less than 25 ohms is observed correct functioning of the device should be verified Conversion testing Successful VF or VT conversion during arrhythmia conversion testing is no assurance that conversion will occur post operatively Be aware that changes in the patient s condition drug regimen and other factors may change the DFT which may result in nonconversion of the arrhythmia post operatively Verify with a
92. ush the pulse generator pocket with sterile saline solution and ensure there is good contact between the pulse generator and the surrounding tissue of the pocket prior to closing the first layer of tissue and prior to performing Automatic Setup of the device Figure 20 Header suture holes for anchoring the device 11 Perform Automatic Setup as described on page 65 of this manual 64 12 After performing Automatic Setup and with the device mode still set to Therapy Off palpate the subcutaneous electrode while monitoring the real time S ECG on the programmer screen for evidence of inappropriate sensing If inappropriate sensing is observed do not proceed until it is resolved Contact Boston Scientific for assistance if necessary Once the baseline is stable and appropriate sensing is observed set the device mode to Therapy On and conduct defibrillation testing if desired See page 66 of this manual for Defibrillation testing instructions 13 After device setup and defibrillation testing close all incisions Use standard surgical techniques to achieve good tissue contact with both the subcutaneous electrode and pulse generator for example avoiding any air entrapment in the subcutaneous tissue Figure 21 System placement after closure of all incisions Setting up the EMBLEM S ICD Pulse Generator using the Model 3200 S ICD Programmer A brief setup process must be completed before the device can deliver manual or automatic therapy Ad
93. vice automatically selects an appropriate gain setting during the Automatic Setup process The gain can also be manually selected as further explained in the EMBLEM S ICD Programmer User s Manual There are two gain settings 1x Gain 4 mV Selected when the signal amplitude is clipped at the 2x gain setting 2x Gain 2 mV Selected when the signal amplitude is not clipped at this setting Sensing and Tachyarrhythmia Detection The device is designed to prevent inappropriate therapy delivery as a result of noise sensing or multiple counting of individual cardiac cycles This is accomplished by an automatic analysis of sensed signals which includes event detection certification and decision phases Detection Phase During the Detection Phase the device uses a detection threshold to identify sensed events The detection threshold is automatically adjusted continuously using amplitudes of recently detected electrical events In addition detection parameters are modified to increase sensitivity when rapid rates are detected Events detected during the Detection Phase are passed on to the Certification Phase 42 Certification Phase The Certification Phase examines the detections and classifies them as certified cardiac events or as suspect events Certified events are used to ensure that an accurate heart rate is passed to the Decision Phase A suspect event can be one whose pattern and or timing indicates the signal is caused by noise

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