ICD Brochure - Boston Scientific
Contents
1. depletion fear of shocking while conscious fear that shocking capability may be lost imagined shocking fear of device malfunction Refer to the product labeling for specific indications contraindications warnings precautions and adverse events Rx only Rev A Sources 1 Competitive comparisons PHYSICIAN S TECHNICAL MANUAL DYNAGEN EL ICD DYNAGEN MINI ICD INOGEN EL ICD INOGEN MINI ICD ORIGEN EL ICD ORIGEN MINI ICD 2014 page 27 29 PUNCTUA ICD ENERGEN ICD INCEPTA ICD PHYSICIAN S TECHNICAL MANUAL 2012 page 40 41 osto PROTECTA XT VR D314VRM 2013 page 330 Scientific EVERA XT VR DVBB1D4 2013 page 24 AnalyST AnalyST Accel Current Current Accel Fortify Fortify ST Promote Promote Accel Promote Advancing science for life O Unify Devices User s Manual 2013 page 29 St Jude Medical High Voltage Devices User s Manual 2013 page 16 Rhythm Management llesto 7 Family of ICDs and CRT Ds Technical Manual 2013 page 217 y g One Boston Scientific Place Natick MA 01760 1537 USA www bostonscientific com 220 smaller and 24 thinner defined by volume Comparison of BSC MINI VR ICD and Medtronic EVERA XT VR DVBB1D4 2013 page 24 3 Based on historical industry average longevity from published sources Medical Professionals 1 800 CARDIAC 227 3422 Horlbeck FW Mellert F Kreuz J Nickenig G Schwab JO Real world data on the lif2. In a double blinded study 27 out of 30 ICD patients compared to devices offered by other manufacturers based on size and thinness Hiiiittiti CUTTTTT of 30 preferred MINI eed MINI Patient Preference Study January 2014 Double blind focus group and questionnaire administered by 3rd party vendor conducted among 30 device patients Do you prefer the overall size shape thinness of MINI over competitive ICDs Yes No Devices tested include the MINI VR ICD Fortity VR ICD Ellipse VR ICD Protecta VR ICD and Evera VR ICD Patients care about device size Td like t to be really thin just dont want to notice it lm going to be concerned about it get some ache when lay on my left side I d rather have it be smaller Seatbelts bother me so much it makes me more aware of it The DYNAGEN INOGEN ICD from Boston Scientific INDICATIONS AND USAGE Boston Scientific implantable cardioverter defibrillators ICDs are intended to provide ventricular antitachycardia pacing ATP and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias CONTRAINDICATIONS Use of these Boston Scientific pulse generators are contraindicated for the following patients whose ventricular tachyarrhythmias may have reversible cause such as digitalis intoxication electrolyte imbalance hypoxia sepsis or patients whose ventricular tachyarrhythmias have a transient cause such as acute myo
3. acardiac stimulation muscle nerve stimulation failure to convert an induced arrhythmia fluid accumulation foreign body rejection phenomena formation of hematomas or seromas heart block heart failure following chronic RV apical pacing inability to defibrillate or pace inappropriate therapy e g shocks and antitachycardia pacing ATP where applicable pacing incisional pain incomplete lead connection with pulse generator infection including endocarditis insulating myocardium during defibrillation with internal or external paddles lead dislodgment lead fracture lead insulation breakage or abrasion lead perforation lead tip deformation and or breakage local tissue reaction loss of capture myocardial infarction MI myocardial necrosis myocardial trauma e g tissue damage valve damage myopotential sensing oversensing undersensing pacemaker mediated tachycardia PMT Applies to dual chamber devices only pericardial rub effusion pneumothorax pulse generator migration shunting current during defibrillation with internal or external paddles tachyarrhythmias which include acceleration of arrhythmias and early recurrent atrial fibrillation thrombosis thromboemboli valve damage venous occlusion venous trauma e g perforation dissection erosion worsening heart failure Patients may develop psychological intolerance to a pulse generator system and may experience the following dependency depression fear of premature battery
4. age RV pacing in patients with varying degrees of conduction block Diagnostics for HF Management HF PERSPECTIV feature provides the only system with a weight alert and an in can diagnostic measuring respiratory rate RRT Respiratory Rate Trend
5. cardial infarction MI electrocution drowning or patients who have a unipolar pacemaker WARNINGS Read this manual thoroughly before implantation to avoid damage to the pulse generator and or lead For single patient use only Do not reuse reprocess or resterilize Program the pulse generator Tachy Mode s to Off during implant explant or postmortem procedures to avoid inadvertent high voltage shocks Always have external defibrillation equipment available during implant and electrophysiologic testing Ensure that an external defibrillator and medical personnel skilled in CPR are present during post implant device testing should the patient require external rescue Patients should 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 Do not expose a patient to MRI scanning Do not subject a patient with an implanted pulse generator and or lead to diathermy If desired ensure that Patient Triggered Monitor is enabled prior to sending the patient home Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored or after 60 days have elapsed from the day that Store EGM was enabled the patient should not apply the magnet Do not use this pulse generator with another pulse generator Do not kink twist or braid the lead with other
6. espan of implantable Patients and Families cardioverter defibrillators depending on manufacturers and the amount of ventricular pacing J Cardiovasc Electrophysiol 1 866 484 3268 December 2012 23 12 1336 1342 Kallinen L et al 2009 http spo escardio org eslides view aspx eevtid 33 amp id 1913 Schaer BA Koller MT Sticherling C Altmann D Joerg L Osswald S Longevity of implantable cardioverter defibrillators influencing factors and comparison to industry projected longevity Heart Rhythm December 2009 6 12 1737 1743 Thijssen J Borleffs CJ van Rees JB et al Implantable cardioverter defibrillator longevity under clinical circumstances an analysis according to device type generation and manufacturer Heart Rhythm April 2012 9 4 513 519 2014 Boston Scientific Corporation or its affiliates All rights reserved CRM 233722 AA APR2014 Knops P Theuns DA Res JC Jordaens L Analysis of implantable defibrillator longevity under clinical circumstances implications for device selection Pacing Clin Electrophysiol October 2009 32 10 1276 1285 Boston Scientific Advancing science for life Tiny can huge breakthrough The world s smallest and thinnest ICD Boston Scientific provides devices tailored to individual needs Up to 20 smaller and 24 thinner than other ICDs on the market the MINI offers all the power of a Boston Scientific ICD in a device that is the industry s sleekest and designed for pa
7. leads as doing so could cause lead insulation abrasion damage or conductor damage Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias For leads that require the use of a Connector Tool use caution handling the lead terminal when the Connector Tool is not present on the lead Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA alligator clips ECG connections forceps hemostats and clamps Do not contact any other portion of the DF4 LLHH or DF4 LLHO lead terminal other than the terminal pin even when the lead cap is in place PRECAUTIONS For specific information on precautions refer to the following sections of the product labeling 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 Based on the literature and on pulse generator and or lead implant experience the following alphabetical list includes the possible adverse events associated with implantation of products described in this literature air embolism allergic reaction bleeding cardiac tamponade chronic nerve damage component failure conductor coil fracture death elevated thresholds erosion excessive fibrotic tissue growth extr
8. tient comfort Implant Experience The MINI ICD provides up to a 20 reduction in pocket bulk when compared to other devices which can enable e Smaller incision at initial implant e Easier device replacement e Lower risk of pocket revision complications Volume Thinness Boston Scientific MINI 26 5cc 9 9mm Boston Scientific INCEPTA ENERGEN 30 5cc 9 9mm Medtronic Evera 33cc 13mm St Jude Ellispse S0CC 12mm Biotronik llesto 7 33cc 11mm Smallest and Thinnest ICD History of Innovation Uncompromised Feature Set In 1985 we introduced the world s first ICD AID B BR AUTOM AIG e 160cc IMPILANTABIe e 30 33 Joules delivered eit ae Model AID B Oo Longevity of lez Vvears S BI400084 a e No programmability 6 ee CN mec systems AcuSheck In 2014 we are introducing the world s smallest and thinnest ICD DYNAGEN MINI ICD e 76 5CC e 35 Joules delivered 41 joules stored e Standard longevity e Uncompromised feature set Lead Reliability ENDOTAK RELIANCE Lead Family maintains the same core design elements that have made Boston Scientific the leader in ICD lead reliability for the past 20 years Appropriate Therapy AcuShock Advanced Therapy is designed to help you better understand your patients arrhythmias and reduce inappropriate therapy Appropriate Pacing RYTHMIO and AV Search features give clinicians options to appropriately man
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