Guide Device failure.. - Tehran Arrhythmia Center
Contents
1. Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device center must maintain an up to date record of all im planted devices including serial numbers and im plant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participating in the global surveil lance of the performance of these devices by mak ing returns to national and or international audit bodies PACE Vol 29 The Society has considered the information provided by Guidant and notes the very low prob ability of life threatening patient injury In regard of these events and waiting for fur ther information particularly about identification of possible new cases or new types of failure ECAS considers that recommendations suggested by the manufacturer are adequate to assure patient safety Recommendation ECAS ICD 04 2006 DEVICE Guidant CONTAK RENEWAL Model H135 and CONTAK RENEWAL 2 Model H155 Background On July 17 2005 Guidant Corporation noti fied the FDA of safety information regarding the CONTAK RENEWAL Model H135 and CONTAK RENEWAL 2 Model H155 cardiac resynchroniza tion therapy defibrillators CRT Ds manufactured on or before August 26 2004 The FDA has indi cated that it will classify them as recalls Physi cians were informed of this failure by letter from Guida2. Provide the patient with full information re garding the risk of early battery discharge high lighting the fact that the risk is currently known to be very low Each decision must be made on the basis of the unique features of each patient How ever ECAS suggest that A the device be replaced if at least one of the following conditions is met 1 The patient is pacemaker dependent 2 The patient has undergone a sec ondary prevention implant for cardiac arrest or syncopal ventricular tachycardia VT 3 The patient has received appropriate therapy for VT or Ventricular fibrillation VF B the patient be reassured and subjected to regular checkups at intervals of not more than 3 months if 1 the patient has a reliable spontaneous rhythm 2 implant was indicated for primary prevention 3 the patient has not required therapy for VT VF C individualized assessment be conducted if 1 sinus bradycardia and or II or III de gree AV block with a good escape rhythm fre quency over 40 beats min is present 2 implant was indicated for secondary prevention following nonsyncopal VT not requiring cardiopulmonary resuscitation or electrical cardioversion 3 the patient has received appropri ate antitachycardia pacing ATP therapy but no shocks assessment must be made of the hemodynamic tolerance of the treated tachy cardias 4 the battery has exceeded 50 of its expected life D the device be replaced in a
3. MERIDIAN PUL SAR MAX II DISCOVERY II VIRTUS PLUS II IN TELIS II and CONTAK TR pacemakers manufac tured between November 25 1997 and October 26 2000 The communication reports that a hermetic sealing component used in these devices may grad ually degrade resulting in a higher than normal moisture content within the pacemaker case late in the device s service life This may lead to one or more of the following behaviors 1 Premature battery depletion resulting in loss of telemetry and or loss of pacing output with out warning June 2006 663 SANTINI ET AL 2 Inappropriate accelerometer function if programmed ON resulting in 3 Sustained pacing at the programmed max imum sensor rate MSR 4 Lack of appropriate accelerometer rate re sponse during activity 5 Appearance of a reset warning message upon interrogation 6 Inappropriate early display of replacement indicators Guidant underline that up to date failing de vices can be identified during usual follow up and has not identified any test that will predict if a de vice will exhibit this failure mode in the future Disabling accelerometer function will prevent inappropriate MSR pacing but moisture penetra tion can still cause the other behaviors described above As of July 11 2005 Guidant has identified 69 devices that may have exhibited this failure mode Of the 78 000 devices originally distributed approximately 28 000 devices remain
4. be reported to the Manufacturer and to ECAS ECAS will create a general database for device failures which will be made available for online access in the ECAS website Recommendation ECAS DF IPG 03 2006 DEVICE ELA Medical Symphony and Rhapsody Pacemakers Background On October 25 2005 ELA Medical sent a letter to device implanting physicians containing impor tant information about the performance of their de vices During routine product surveillance moni toring a situation of no output has been observed in a limited number of Symphony or Rhapsody pacemakers models Symphony DR 2550 Rhap sody DR 2530 Rhapsody DR 2510 Rhapsody D 2410 Rhapsody SR 2210 produced before August 1 2003 The no output condition could be due to a metallic migration caused by a specific man ufacturing process No criteria for device failure prediction has been identified with usual surveil lance techniques No evidence of metallic migra tion has been identified in pacemakers produced after August 1 2003 Incidence e In these pacemakers produced before August 1 2003 the overall percentage world PACE Vol 29 wide of device failure has been reported to be 0 75 e Inthe pacemakers produced after August 1 2003 there has been no report of device failure The following recommendations were made by ELA e The manufacturer suggests that pacemaker dependent patients who have received a pace maker manufactured befo
5. has been ob served in any devices shipped after March 12 2004 Guidant s modeling based on field experi ence and statistical analysis predicts the failure rate for the active device population of 41 000 to be between 0 017 and 0 037 over the remaining device lifetime thus anticipating approximately seven to fifteen additional failures Second Failure Mode As of September 6 2005 16 failures associated with a second failure mode have been confirmed out of 341 000 INSIGNIA and NEXUS devices dis tributed worldwide 0 0047 For all sixteen de vices a no output condition was exhibited at the implant procedure or preimplant testing Guidant has received one report of a pacemaker dependent patient experiencing syncope and resuscitated car diac arrest that occurred in association with loss 666 June 2006 of pacing output during an elective pulse genera tor replacement procedure Root cause analysis is ongoing a specific root cause for this observation has not yet been determined Guidant Recommendations Regarding First Failure Mode Physicians should consider the projected low and declining failure rate in addition to the unique needs of individual patients in their medical deci sions regarding patient management Guidant rec ommends normal monitoring in agreement with the instructions contained in the device label ing Guidant also recommends advising patients to seek for immediate clinical attention if they ex peri
6. have been implanted and there has been no reported failure 2 28 failures have been reported in Germany Australia and the United States and the relevant regulatory bodies were informed according to laws in those countries 3 On May 24 2005 Guidant notified physi cians and implanting centers that the rate of occur rence of the failure is 0 1 per implant 0 002 per month 4 Guidant recommends 3 month follow up intervals for these devices 5 Guidant does not recommend replacement of these devices prior to the appearance of normal ERIs 6 Patients implanted with potentially af fected PRIZM 2 DR ICDs should consult their follow up clinic in the event that they receive a defibrillation shock where their clinical situation will be analyzed 7 Ifa patient or a physician decides to re place a device that was manufactured prior to November 13 2002 that has not reached ERI yet Guidant will provide a replacement device at no June 2006 655 SANTINI ET AL cost under the PRIZM 2 DR Warranty Supplement Program Concerning the 28 identified device fail ures Guidant provided an analytical report with specific faults detected in each case The faults included inability to recognize ventricular tachyarrhythmia inability to deliver an effec tive shock permanent loss of pacing therapy device reset to fallback safety mode loss of teleme try programming interrogation programmer dis play of a red warning screen on at
7. if the risk of no output is low the ab sence of failure predicting criteria should be con sidered in determining our final clinical judge ment With regard to these events and while waiting for further information particularly the identifica tion of new cases or new types of failure ECAS suggests that June 2006 667 SANTINI ET AL A to consider only for those patients with pacemaker manufactured before August 1 2003 pacemaker replacement if at least one of the fol lowing conditions is met 1 The patient is pacemaker dependent 2 The patient could suffer from symp tomatic deterioration such as syncope presyncope or heart failure in the event of sudden loss of pacing B Routine follow up visits every 6 months in all the other patients In case of prophylactic replacement in high risk patients ECAS believes that the manufacturer must provide a replacement device at no charge and reimburse related medical expenses as actual guarantee rules state Recommendation ECAS DF IPG 04 2006 DEVICE Medtronic Sigma Pacemaker Background On December 5 2005 Medtronic sent a let ter to device implanting physicians containing important information about the performance of their devices Specifically the manufacturer fur nished information regarding an anomalous be havior recorded during tests performed on devices returned for analysis The failure is related to a specific and lim ited number of pacema
8. in all the other patients June 2006 669
9. low Recommendation ECAS DF IPG 02 2006 Suggestions for Managing Guidant Pacemakers INSIGNIA and NEXUS Patients On September 22 2005 Guidant sent a letter to doctors where important medical device safety information is provided regarding a subset of men tioned pacemakers manufactured by March 12 2004 Ref The communication concern the following model number INSIGNIA Entra SSI 0484 0485 NEXUS Entra SSI 1325 1326 INSIGNIA Entra DDD 0985 0986 NEXUS Entra DDD 1425 1426 INSIGNIA Entra SR 1195 1198 NEXUS Entra SR 1395 1398 INSIGNIA Entra DR 1294 1295 1296 NEXUS Entra DR 1466 1494 1495 INSIGNIA Ul tra SR 1190 NEXUS Ultra SR 1390 INSIGNA Ultra DR 1290 1291 NEXUS Ultra DR 1490 1491 INSIGNIA Plus SR 1194 NEXUS Plus SR 1394 INSIGNIA Plus DR 1297 1298 NEXUS Plus DR 1467 1468 INSIGNIA AVT SSI 482 NEXUS AVT SSI 1328 INSIGNIA AVT VDD 882 NEXUS AVT VDD 1428 INSIGNIA AVT DDD 982 NEXUS AVT DDD 1432 INSIGNIA AVT SR 1192 NEXUS AVT SR 1392 INSIGNIA AVT DR 1292 NEXUS AVT DR 1492 The communication reports that Guidant s Cardiac Rhythm Management Quality System has identified two separate failure modes each oc curring infrequently within the INSIGNIA and NEXUS families of implantable pacemakers One June 2006 665 SANTINI ET AL or more of the following device behaviors may be observed e Intermittent or permanent loss of pacing output without warning e Intermittent or permanent loss of te
10. reflect the opinions of a small number of European cardiologists experienced in the field of cardiac pacing and electrophysiology The rec ommendations are not obligatory on implanting physicians but are intended as a potential help in their daily practice The final decision will always remain with the patients and their doctors who will need to evalu ate each case individually and make the most ap propriate decision Section I ICDs Recommendation ECAS DF ICD 01 2006 DEVICE Medtronic Marquis implantable defibrillators Background Medtronic has notified European pacemaker and ICD implanting centers that defibrillator mod els 7230 7232 7274 7277 7278 7279 7285 7289 belonging to the Marquis family and supplied with batteries produced before December 2003 could be subject to a rapid discharge of the battery due to a short circuit in the battery The company has reported receiving 9 units exhibiting this abnormal behavior So far 87 000 such devices have been implanted worldwide 18 000 in Europe and clinical practice shows that the present risk of malfunctioning is 0 01 The risk is expected to increase with time a higher risk of malfunction is expected in the second half of the predicted battery life Laboratory tests have fore cast that the risk of malfunctioning ranges between 0 2 and 1 5 in the second half of the life of the battery Devices belonging to the same series but with batteries produced after Dece
11. result in less than the full number of programmed shocks being available for delivery during that episode but all delivered shocks would be at their programmed energy This behavior was discovered as an inci dental finding during analysis of one returned de vice that had delivered a large number of high voltage shocks over a short time period A second anomaly has been identified and is caused by electrical noise generated as a re sult of the charging of the device s high voltage June 2006 659 SANTINI ET AL capacitors After a capacitor charge if rate re sponsive pacing mode e g DDDR VVIR etc is programmed On this noise may be inter preted by the device s accelerometer activity sen sor as physical activity causing a temporary in crease in the pacing rate that may persist after charging is completed The degree and duration of the rate increase will depend on a variety of factors but the rate will never exceed the pro grammed maximum sensor rate MSR and the device will gradually return to the appropriate rate This anomalous behavior which has been observed during the performance of manual ca pacitor maintenance has been traced back to a component supplied to St Jude Medical by one vendor therefore only the subset of device models that were manufactured with the affected compo nent device serial numbers below 141000 for any model will exhibit this behavior The company is request
12. the patient be asked to sign a form indicating that he or she has been informed of the risks and that he or she un derstands and agrees with the choices made In case of device replacement because of the possibility of surgical complications it is recom mended that the informed consent form contains 1 a statement indicating that the patient is aware that replacement will be performed solely as a precautionary measure and 2 astatement summarizing the risks and con sequences of device failure and the risks of device replacement For example in addition I am aware of the fact that the replacement of the device is solely a precautionary measure as a risk of early and sud den discharge of the battery has been identified in a series ofimplantable defibrillators of the same se ries as mine The current risk which has emerged from clinical practice is of 0 01 and it is es timated to range between 0 2 and 1 5 in the second half of the functional life of the battery Recommendation ECAS DF ICD 02 2006 DEVICE Guidant Cardioverter Defibrillators VENTAK PRIZM 2 DR Model 1861 Background On May 23 2005 a letter from Guidant was sent to physicians in which information about the performance of cardioverter defibrillators VENTAK PRIZM 2 DR was provided This in formed of a failure involving deterioration in a wire insulator within the lead connector block PACE Vol 29 that in conjunction with other factors resul
13. CAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS Specifically it has been identified that this memory chip can rarely be affected by back ground levels of atmospheric ionizing cosmic radi ation background cosmic radiation causing an anomaly and triggering a high current drain This condition has been replicated by St Jude Medi cal in a nuclear laboratory and confirmed by the manufacturer of this component The anomaly can trigger a temporary loss of pacing function and per manent loss of defibrillation support There are no tests to predict ifa particular device s memory chip component will exhibit this specific anomaly To date St Jude Medical have reported 60 anomalies out of 36 000 devices implanted world wide 1 67 with 53 of these being observed fol lowing device implantation and seven prior to de vice implantion To date 26 000 devices are still in service about 8 000 of these are in service in mar kets outside the United States There has been no serious injury or death attributable to this anomaly The nature of the anomaly is random and constant over time The estimated incidence is 2 57 over the 5 year projected life of each device St Jude points out that from 2002 a differ ent design of a different vendor s SRAM memory chip component has been used in their devices Laboratory testing and clinical experience indicate that this newer generation memory chip compo nent does not share the same susceptibi
14. ES AND COMPLICATIONS Recommendation ECAS ICD 05 2006 DEVICE Guidant Cardioverter Defibrillators CONTAK RENEWAL 3 E 4 CONTAK RENEWAL 3 e 4 AVT e RENEWAL RF Background On June 23 2005 Guidant Corporation noti fied the FDA that a letter had been sent to physi cians regarding safety of some devices CONTAK RENEWAL 3 E 4 CONTAK RENEWAL 3 e 4 AVT e RENEWAL RF The aim of the letter was to inform physicians and to limit possible adverse events The FDA classified this enterprise as a recall The evaluation of the failure is in a very early phase and the distribution and implant of these devices has been interrupted until the eval uation will be complete Quality analysis identi fied a potential defect of a component that can limit the available therapies Engineering analy sis determined that a mode change with a magnet can be blocked in the close position Four events in circa 46 000 implanted devices have been con firmed and a fifth event is under evaluation In the documented events the patients and or physicians were alerted by sounds from the devices signalling the block in close position of the mode change with a magnet In these events the devices were replaced No severe injury to patients has been reported If mode change with a magnet is blocked in the close position the therapy of atrial and ventricular tachyarrhythmias is inhibited whereas antibrady cardia pacing is conserved In this condition the safety functi
15. POLICY STATEMENT Recommendations of the European Cardiac Arrhythmia Society Committee on Device Failures and Complications MASSIMO SANTINI JOHANNES BRACHMANN t RICCARDO CAPPATO WYN DAVIES JERONIMO FARRE SAMUEL LEVY AURELIO QUESADA RENATO P RICCI EDWARD ROWLAND tt NEIL SULKE From San Filipo Neri Hospital Rome Italy Klinikum Coburg Germany Policlinico S Donato Milan Italy St Mary Hospital London UK Fundacion Jimenez Diaz Madrid Spain H pital Nord des Bourrellys Marseille France Hospital General University of Valencia Spain San Filippo Neri Hospital ttSt George Medical School London UK Eastbourne General Hospital Sussex UK Introduction Throughout the history of cardiac pacing mal functions of implanted devices and leads have pre sented clinical problems for the implanting physi cians It is clear that any electronic apparatus may fail through a variety of possible unpredictable malfunctions These occur despite best practice by the devices manufacturers and the implanting physicians The importance has recently been em phasized of the need for a system 1 for follow up of devices which is able to promptly identify actual or potential malfunc tions 2 that informs the physicians and patients promptly and transparently in order to allow them to organize the most appropriate diagnostic or ther apeutic strategy 3 that guarantees the best protection for the patie
16. The Society takes note of the information pro vided by the manufacturing company and of the consequent lack of clinical complications related to these anomalies In the light of the data pro vided we consider that the software correction is sufficient to properly assure patients safety We recommend that physicians ensure that they iden tify patients in their care with affected devices ensure that the new software is downloaded into all the relevant programmers as soon as possible and that software upgrade of those devices is per formed with minimal delay As with all these devices ECAS recommends even greater clinical surveillance of these patients paying particular attention to look for any com plications that might result from these or other reported anomalies and to report to ECAS any com ments that may be helpful for the optimum man agement of patients with these devices Recommendation ECAS DF ICD 07 2006 Recommendations for Management of Patients with the Following St Jude Medical ICD Models Photon DR V 230HV a few Serial Numbers Photon Micro VR DR V 194 V 232 and Atlas VR DR V 199 V 240 On October 6 2005 St Jude Medical Inc sent a letter to cardiac pacing centers that indicated a possible functioning anomaly regarding a memory chip called static random access memory SRAM used in some ICD products within the Photon and Photon Micro device families and in certain Atlas devices PACE Vol 29 E
17. and in order to ensure the highest standard of patient care ECAS suggests that A the device replacement should be consid ered if at least one of the following conditions is met 1 The patient underwent device im plantation as secondary prevention following cardiac arrest or ventricular tachycardia asso ciated with hemodynamic collapse syncope or near syncope 2 The patient has required appropriate therapy for VT or VF 3 The patient is pacemaker dependent Such individual risk assessment may in dicate the need for elective device replace ment in some patients The risk analysis should be explained to the patient including the risks associated with device replacement In case of prophylactic replacement in high risk patients ECAS believes that the manu facturer must provide a replacement device at no charge and reimburse related medical expenses B That an individual analysis of each pa tient with a potentially affected device be per formed and suggest periodic follow up every 3 months when 1 the indication for implantation was primary prevention and the patient has not required therapy for VT or VF 2 the indication for implantation was secondary prevention but only for hemody namically well tolerated VT with LVEF gt 35 and without need for cardiac resynchroniza tion or shock therapy PACE Vol 29 3 the patient received appropriate ATP therapy and no shock therapy for hemody namically well tolera
18. as not completely eliminated A statistical analysis identified two more ICD groups presenting with a very low metallic migra tion incidence causing this fault Incidence e Ina first group of 430 devices produced between April and July 2003 the incidence of the problem is 2 6 e In a second group of 1 856 devices pro duced between August 2003 and August 2004 the incidence of the problem is 0 1 Corrective Management of the Phenomenon by Manufacturing Society e In July 2003 ELA eliminated a phase of the manufacturing process in which the circuits were exposed to high temperature in order to elim inate completely the delamination of a protective covering of high voltage hybrid circuit and subse quently metallic migration in this circuit So far devices produced after July 2003 have not demon strated the fault e Welding and covering processes of the low voltage hybrid circuit have been modified after August 2004 with the aim of eliminating the resid ual probability of the fault No evidence of the fault has been seen on devices produced after August 2004 The Following Recommendations were made by ELA e Patients implanted with the first group of devices should undergo a device follow up visit every 3 months in accordance with the recom mendations reported in the user manual Depend ing on the circumstances patients with frequent ventricular fibrillation episodes and pacemaker dependent patients should be conside
19. ement It should also be taken into consideration that in some instances the device may have been im planted for 3 years and therefore not far from the time for elective replacement We recommend that the patients be asked to sign a form indicating that they have been in formed of the risks and that they understand and agree with the choices made In case of device replacement because of the possibility of surgical complications it is recom mended that the informed consent form contains a statement indicating that the patient is aware that replacement will be performed solely as a precau tionary measure and a statement summarizing the risks and consequences of device failure and the risks of device replacement Recommendation ECAS ICD 03 2006 DEVICE Guidant VENTAK PRIZM AVT VITALITY AVT RENEWAL 3 AVT and RENEWAL 4 AVT Background On July 11 2005 Guidant Corporation no tified the FDA of safety information regarding its cardioverter defibrillators with atrial ther apy VENTAK PRIZM AVT VITALITY AVT and CONTAK RENEWAL AVT devices These models are subject to a condition in which memory corruption may result in functional latching which limits available therapy At that time PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS two occurrences had been confirmed out of ap proximately 20 950 devices implanted worldwide Guidant recommends a programming change that reduces the risk of this issue t
20. ence syncope or lightheadedness Guidant Recommendations Regarding Second Failure Mode Guidant recommends verification of pace maker operation in the packaging prior to the im plant procedure Devices exhibiting intermittent or permanent loss of output or telemetry should not be implanted Physicians should consider in addition to the unique needs of individual pa tients both the very low occurrence rate and that no failure has been observed after successful con firmation of pacing at implant in their clinical de cisions regarding patient management ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be identi fied This responsibility includes undertaking en hanced follow up according to current recommen dations and participating in the global surveillance of the performance of these devices by making re turns to national and or international audit bodies ECAS suggests that in order to ensure the high est standard of patient care the risk profile of each patient with a potentially affected device should be assessed individually and their device assessed in detail as recommended by Guidant The Society has reviewed information pro vided by the company and u
21. enti fied This responsibility includes undertaking en hanced follow up according to current recommen dations and participating in the global surveillance of the performance of these devices by making re turns to national and or international audit bodies ECAS suggests that in order to ensure the high est standard of patient care the risk profile of each patient with a potentially affected device should be assessed individually and their device assessed in detail as recommended by Guidant The Society has reviewed the information pro vided by the company and takes note of the low reported risk of generator failure Recognizing that because of underreporting the risk rate may be greater than that currently noted we encourage all colleagues to report to ECAS the manufacturer and relevant regulatory authorities any further cases that have been iden tified or become apparent Although the risk of generator failure is low failure cannot be predicted and failure can result PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS in abrupt loss of pacing output In our opinion these elements should guide clinical decisions With regard to these events and while waiting for further information particularly the identifica tion of new cases or new types of failure ECAS suggests that A the pacemaker be replaced if at least one of the following conditions is met 1 The patient is pacemaker dependent 2 The pa
22. equency of pro grammed follow ups This increases the likelihood 664 June 2006 of detecting a failure that has already occurred but does not guarantee that the device will not exhibit this failure mode in the future At each follow up 1 Evaluate the patient s clinical condition 2 Evaluate battery status indicator gas gauge for signs of early or rapid depletion be tween sequential follow up visits 3 Evaluate the accelerometer rate response 4 Look for inappropriate MSR pacing or pac ing higher than the programmed lower rate limit while the patient is at rest 5 Look for lack of rate response with activity Many of these devices are nearing or have ex ceeded their estimated longevity and have thus outlived their warranty Even if a device is no longer covered by warranty Guidant will provide a replacement device at no charge for pacemaker dependent patients and other patients deemed by their physicians to be best served by replacement provided the replacement occurs prior to the nor mal appearance of ERI This supplemental war ranty program was available through December 31 2005 ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be id
23. g in the global surveil lance of the performance of these devices by mak ing returns to national and or international audit bodies The Society has considered the information provided by Guidant and notes the very low inci dence of malfunction reported and the absence of life threatening patient injury In regard of these events and waiting for fur ther information particularly about identification of possible new cases or new types of failure ECAS considers that recommendations suggested by the manufacturer are adequate to assure patient safety Recommendation ECAS ICD 06 2006 DEVICES St Jude Medical ICD models Epic DR HF V 233 V 337 V 338 Epic Plus DR VR HF V 236 V 239 V196 V 239T V 196T V 350 Atlas DR V 242 and Atlas Plus DR VR HF V 243 V193 V 193C V 340 V 341 V 343 Background On June 17 2005 St Jude Medical sent a let ter to device implanting physicians regarding two anomalies that St Jude Medical has uncovered during routine product monitoring The first anomaly can occur when one of the affected devices attempts to deliver multiple shocks in rapid succession Due to a device soft ware anomaly it is possible that when the device s battery is nearing its ERI a charging cycle may be skipped If this were to occur the first shock will always be delivered as programmed and if needed the next shock in the programmed se quence would be delivered after a delay of 2 4 seconds A skipped charge would
24. hat can be im plemented at the next scheduled follow up visit Guidant developed a noninvasive software solu tion for VITALITY AVT and all RENEWAL AVT devices This solution should have been available in the fourth quarter of 2005 pending regulatory approval Guidant have further clarified that 1 latching of AVT devices will suspend de tection and treatment of atrial and ventricular ar rhythmias Telemetry and programming are not available Bradycardia pacing may continue but will not be programmable and may not match pro grammed settings In a latched state battery us age may increase but battery status indicators will not be available In the extremely unlikely circum stance that latching occurs during delivery of ATP therapy ATP therapy delivery could continue in dependent of patient need 2 device replacement is required if latching occurs The recommendations suggested by the man ufacturers are e verify normal device function using routine clinical follow up procedures e program Atrial Tachy Episode Data Stor age to 0 e evaluate the risks and benefits of temporar ily programming ATP therapy OFF Current estimates of the rate of occurrence of this malfunction are 0 005 if second and third recommendations are applied the risk reduces by 0 000066 Following implementation of the software so lution the estimated probability of latching is Zero ECAS Committee Statement and Recommendations
25. hm rate over 40 beats min 3 Patients with heart failure Such individual risk assessment may in dicate the need for elective device replace ment in some patients The risk analysis should be explained to the patient including the risks associated with device replacement In case of prophylactic replacement in high risk patients ECAS believes that the manu facturer must provide a replacement device at no charge and reimburse related medical expenses PACE Vol 29 We recommend patients be asked to sign a form indicating that they have been in formed of the risks and that they understand and agrees with the choices made In case of device replacement because of the possibility of surgical complications it is recommended that the informed consent form contains a statement indicating that the patient is aware that replacement will be per formed solely as a precautionary measure and a statement summarizing the risks and con sequences of device failure and the risks of device replacement C A 3 months follow up routine be main tained in patients with 1 Good spontaneous rhythm 2 Normal chronotropic response 3 Absence of heart failure As far as the rate response function is con cerned we recommend that the default position should be for deactivation In our opinion it can be maintained ON only in the absence of ischemia and or heart failure and only if the maximum sen sor pacing rate is programmed relatively
26. implanted worldwide 18 000 of these devices remain in ser vice in the United States with an average implant age of 69 months No failure has been reported prior to 44 months of service and the likelihood of occurrence increases with implant time Present estimates of the rate of failure in the remaining active implanted devices are between 0 17 and 0 51 over the remaining device life time The actual occurrence rate and predicted rate may be greater than the stated numbers because of underreporting In those cases observed to date there have been a variety of serious complications In 20 patients loss of pacing output occurred including 5 pa tients who experienced syncope and presyncope requiring hospitalization in the remainder There have been two reports of sustained MSR pacing where heart failure may have developed as a con sequence In one report a patient whose device exhibited sustained MSR pacing was admitted to the hospital and later expired The following recommendations were made by Guidant 1 Consider replacing devices for pacemaker dependent patients 2 Advise patients to seek physician s atten tion if they notice a prolonged rapid heart rate experience syncope or lightheadedness or have symptoms of heart failure 3 Select a suitable MSR setting given the rare possibility that inappropriate sustained pac ing at MSR can occur or consider programming the accelerometer OFF 4 Consider increasing the fr
27. in cidence of malfunction reported and the absence of life threatening patient injury in the cases of de vice failure reported Recognizing that because of underreporting the risk rate may be greater than that currently noted we encourage all colleagues to report to ECAS the manufacturer and relevant regulatory authorities any further cases that have been iden tified or become apparent Although the risk of failure is low and in only a minority ofthe cases did the anomaly present as a failure in impulse delivery the inability to predict criteria failure should be considered in making the final clinical judgement PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS In order to maintain the highest level of patient care we recommend performing an individual evaluation of every single patient with risk assessment profile through a reevaluation of patients files identifying the patients with the higher risk With regard to these events and while waiting for further information particularly the identifica tion of new cases or new types of failure ECAS suggests that PACE Vol 29 A that pacemaker replacement be consid ered if at least one of the following conditions is met e The patient is pacemaker dependent e The patient could suffer from symp tomatic deterioration such as syncope presyncope or heart failure in the event of sudden loss of pacing B Routine follow up visits every 6 months
28. ing that nonimplanted devices with these serial numbers be returned to St Jude Medical These anomalies potentially affect approxi mately 9 600 ICDs distributed in Europe the Mid dle East and Africa No clinical complication re lated to these anomalies has been identified so far St Jude Medical has developed programmer software that will automatically detect the affected ICDs and download device software that will en able the skipped charge anomaly to be corrected Once the upgrade is performed the potential for a skipped charge will be eliminated Additionally if the rate responsive mode is programmed On devices with serial numbers below 141000 will have their rate response functions suspended for the time period during which the electrical noise could be present i e while significant residual voltage remains on the high voltage capacitors appropriate nonrate responsive pacing at the pro grammed base rate will continue to be provided The period during which rate response is sus pended may last anywhere from a few minutes to approximately 90 minutes If rate responsive pacing was ongoing prior to charging the pac ing rate will gradually decrease to the base pacing rate according to the normal rate response recov ery algorithm and will remain there while rate re sponsive pacing is suspended The rate response behavior for devices with serial number greater than 141000 will not be affected by the software downl
29. kers belonging to the Sigma model that could present an anomalous behavior due to a disconnection of some electrical links at the level of the hybrid circuit Clinically this anomalous behavior could present as the following no rate response rapid battery discharge high impedance of the electrode catheters complete or intermittent loss of teleme try or loss of impulse delivery No death or patient injury has been attributed to this fault At the level of the terminal blocks of the hy brid circuit the disconnection of some electrical links has been discovered During October 2005 tests were completed that identified the cause of this anomaly as the use of a particular solvent to clean the hybrid circuits This particular sol vent used in a subgroup of this pacemaker fam ily could reduce the capacity of the electrical connection Incidence Worldwide circa 28 000 devices of this model have been implanted Nineteen devices have been reported with this failure an incidence of 0 068 Only 5 out of 19 devices presented with the no output phenomenon The time interval between implant and failure ranged between 17 and 38 months Medtronic created some predictive mod 668 June 2006 els and the calculated incidence of this failure could reach 0 17 0 30 in the remaining lifetime of these pacemakers No predictive test is avail able to identify the devices that will develop this failure The following recommendations we
30. lemetry e Reversion to VVI mode or appearance of a reset warning message upon interrogation There has been no reported death resulting from these failure modes Loss of pacing output associated with these failure modes has resulted in syncope as well as presyncope requiring hospi talization The communication points out that the United States FDA may classify this communication ac tion as a recall Ref First Failure Mode As of September 6 2005 36 failures associated with a first failure mode have been confirmed out of 49 500 devices distributed worldwide 0 073 Seven of these devices exhibited no output during the implant procedures For devices successfully implanted the majority of failures occurred early in life with a mean implant time of 7 months The likelihood of this failure mode decreases with im plant time and no failure has been reported be yond 22 months of service Guidant has received three reports of syncope and six reports of brady cardia or heart block associated with this failure mode which required emergency hospitalization One device was determined to have failed briefly and resumed functioning with no detectable indi cation of this seen during routine follow up The root cause has been identified as foreign mate rial within a crystal timing component The sup plier of the crystal timing component used in this subset has eliminated foreign material within the crystal chamber and no such failure
31. lity to back ground cosmic radiation as the earlier generation Device Behavior in Case of Malfunction In the event that a device chip is affected by background cosmic radiation the high current drain condition will deplete the battery voltage rapidly This can result in loss of output for a pe riod up to approximately 48 hours During this period the patient would be without pacing or de fibrillation therapy After this initial period the battery will reach a voltage level at which the de vice will enter its Hardware Reset Mode This safety mode is designed to preserve the device s ability to provide VVI pacing support In this mode the device will operate in the VVI mode at 60 ppm but will not be capable of providing tachycardia detection or therapy This may only be notable by a warning message on the programmer screen upon device interrogation St Jude Medical Recommendations 1 Performing routine device monitoring ev ery 3 months 2 In determining whether additional patient management or follow up may be needed con sider the low failure rate for the anomaly and the unique medical needs and situation of each in dividual patient including whether the patient PACE Vol 29 is pacemaker dependent or at high risk for life threatening arrhythmias 3 Ifa device is found in Hardware Reset Mode a device replacement must be arranged as soon as possible 4 Suggest that the patient immediately in forms
32. ll patients who request it after being informed of the situation if they consider the risk of therapy delivery failure to be unacceptable making sure that they are aware of the risks associated with replacement of the de vice For those patients who accept regular follow up adopt the measures recommended above by the manufacturer 1 Conduct quarterly i e every 3 months follow up procedures PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS 2 Inform patients that they should experi ence warmth in the area surrounding the ICD to seek follow up care promptly 3 Program Low Battery Voltage ERI Patient Alert to On High This will result in an audi ble alternating tone in the limited circumstances where a battery depletes slowly over a number of days Data indicate most short circuits will occur rapidly and will not be detected by this feature 4 Also consider providing a handheld mag net to patients to check device status and program the Low Battery Voltage ERI Patient Alert to On High Device operation may be monitored periodically e g daily by patients placing the magnet over the device for 1 2 seconds If the de vice is functional a steady tone will sound for ap proximately 20 seconds If no tone is heard follow up care should be sought promptly The risk analysis should be explained to the patient including the risks associated with device replacement We recommend that
33. m indicating that he or she has been in formed of the risks and that he or she understands and agrees with the choices made In case of device replacement because of the possibility of surgical complications it is recom mended that the informed consent form contains a statement indicating that the patient is aware that replacement will be performed solely as a precau tionary measure and a statement summarizing the risks and consequences of device failure and the risks of device replacement Recommendation ECAS DF ICD 08 2006 DEVICE ELA Medical Cardioverter Defibrillators ALTO DR 614 VR 615 MSP 617 DR 624 VR 625 MSP 627 Models Background ELA Medical gave notification in 2004 that a limited number of cardioverter defibrillators ALTO DR 614 VR 615 MSP 617 DR 624 VR 625 MSP 627 models produced before April 17 2003 could undergo a rapid discharge of the battery or a pro longation of defibrillation charge time caused by a metallic migration consequent upon a specific manufacturing process On July 25 2005 ELA Medical sent a letter to implanting centers in order to supply the in formation and recommendations for the correct management of patients implanted with those de vices The communication reported that ongoing postmarketing surveillance demonstrated a signif icant reduction in incidence of this phenomenon after changes in the manufacturing process after 662 June 2006 April 2003 although the phenomenon w
34. mber 2003 do not exhibit this abnormal behavior The American 2006 The Authors Journal compilation 2006 Blackwell Publishing Inc PACE Vol 29 June 2006 653 SANTINI ET AL Food and Drug Administration FDA has assessed this and classified the action to be taken as a Class II recall Class II recalls indicate a situation in which the use of a device judged at risk may cause injuries which are temporary or reversible with appropriate medical treatment or situations where the risk of seriously adverse events occur ring is judged to be low On February 23 2005 the Heart Rhythm Society published recommen dations regarding the management of devices at risk emphasizing the importance of evaluating the risk of malfunction and taking into account the risks associated with reoperation This rec ommendation is applied to Class I recalls which involve a reasonable probability of the device malfunction causing serious consequences for the patient s health including death In order to fur ther limit the risk of failure to deliver therapy Medtronic put forward the following four recom mendations in an informative note 1 Conduct quarterly i e every 3 months follow up procedures 2 Inform patients that should they experi ence warmth in the area surrounding the ICD they should seek follow up care promptly 3 Program Low Battery Voltage ERI Patient Alert to On High This will result in an audi ble alter
35. nating tone in the event that the battery depletes slowly over a number of days However data indicate that most short circuits will occur rapidly and will not be detected by this feature 4 Also consider providing a handheld mag net to patients to check device status and program the Low Battery Voltage ERI Patient Alert to On High Device operation may be monitored periodically e g daily by patients placing the magnet over the device for 1 2 seconds If the de vice is functional a steady tone will sound for approximately 20 seconds If no tone is heard follow up care should be sought promptly ECAS Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participating in the global surveil lance of the performance of these devices by making returns to national and or international audit bodies As a temporary measure before further in formation is released from the manufacturer re 654 June 2006 garding the identification of new cases of device malfunction it is thought advisable to follow the guidelines reported below for the management of patients
36. nderstands the low reported risk of failures Despite the low expected risk and the declining trend of reported compli cations with a peak at 7 months after the implant the most concerning aspects are the lack of ability to predict device failure and that failure can re sult in loss of pacing output In our opinion these elements should guide clinical decisions PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS Recognizing that because of underreporting the risk rate may be greater than that currently noted we encourage all colleagues to report to ECAS the manufacturer and relevant regulatory authorities any further cases that have been iden tified or become apparent Whilst awaiting any additional information from the manufacturers specifically on additional failure reports we suggest the following guidelines for managing these patients Consider pacemaker replacement if at least one of the following conditions applies 1 The patient is pacemaker dependent 2 The patient could suffer deterioration of symptoms such as syncope presyncope or heart failure with sudden loss of pacing Otherwise arrange to follow the patients on a 3 month basis Hypothesizing that the risk rate may be greater than the numbers reported as of today because of underreporting all data concerning the fail ures found during this effort and the interventions made by each investigator to compensate for the failures should
37. nt The failure involves deterioration of the insulation surrounding a high voltage wire within the lead connector block In conjunction with other factors this can allow shorting of energy to the active titanium case during shock delivery re sulting in the inability of the device to deliver ef fective therapy Fifteen reports of this failure mode have been confirmed from approximately 16 000 devices im planted worldwide This includes an event in which a device was returned after a patient death on May 30 2005 This device is still being tested but it appears to have experienced this failure in conjunction with attempted delivery of at least one high voltage therapy Approximately 11 900 devices built before August 26 2004 remain in service Guidant has further clarified that 1 the current rate of occurrence is 0 094 per implant theoretical estimates indicate that the rate of reported failures may increase between 0 20 and 0 59 2 Guidant recommends normal follow up at 3 month intervals 3 Guidant does not recommend replacement of these devices prior to the appearance of normal ERIs 4 If a patient has recently received high voltage therapy Guidant recommends evaluating the condition of the device and the patient s clin ical situation to determine whether the device should be electively replaced in the event of which Guidant will provide a replacement device at no charge June 2006 657 SANTINI ET AL D
38. nts The year 2005 was a peculiar one with re gard to failures of implanted pacemakers and defibrillators with several manufacturers experi encing at least one device problem These have attracted considerable attention from the lay pub lic and have raised understandable concern for both physicians and patients The European Car diac Arrhythmia Society ECAS has responded to this by the creation of a special Committee for De vice Failures and Complications the aim of which is to generate a reasoned analysis of each individ ual failure and to give the community of implant ing physicians recommendations on how to man age it All the data reported were submitted by the company that had manufactured each device with a problem The advice of the ECAS Committee was in the main in agreement with the manufacturers suggestions Address for reprints Massimo Santini Department of Heart Disease San Filipo Neri Hospital Via G Martinotti 20 Rome 00135 Italy Fax 39 06 33062489 e mail m santini rmnet it Received February 28 2006 accepted February 28 2006 The ECAS Committee appreciated the high level of cooperation received from the manufac turers with regard to either sharing information or aiding the physicians in providing prompt and ap propriate actions for their patients This article must be interpreted solely as pro viding recommendations for the clinical manage ment of the various reported device problems They
39. oad St Jude Medical confirmed that its technical personnel will be installing new software version 4 8 5 onto Model 3510 programmers With this software in place the programmer will upon in terrogation automatically determine whether the ICD requires one or both of the aforementioned software downloads and will prompt the user to continue with the upgrade 660 June 2006 Since a skipped charge is more likely to occur in devices that are closer to their ERI St Jude Med ical recommends that if the next patient follow up is not scheduled to occur within the next 6 months that the patient be seen within this time period In addition if devices are programmed to pacing settings that result in high current consumption such as high output biventricular pacing consid eration should be given to scheduling the patient for a follow up visit within 3 months ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be identi fied This responsibility includes undertaking en hanced follow up according to current recommen dations and participating in the global surveillance of the performance of these devices by making re turns to national and or international audit bodies
40. ocumented failure includes one or more of the following 1 Failure to recognize ventricular tach yarrhythmia 2 Failure to deliver an effective shock 3 Permanent loss of pacing therapy 4 Device reversion to fallback safety mode 5 loss of telemetry programming interroga tion 6 programmer display of a red warning screen upon attempted device interrogation 7 programmer display of yellow warning screen indicating out of range shocking impe dance ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participating in the global surveil lance of the performance of these devices by mak ing returns to national and or international audit bodies The Society has taken note of the informa tion provided by Guidant and of the low prob ability of failure risk 0 1 However it cannot be underestimated that such device failure can lead to a failure to deliver an effective shock and the consequent failure to prevent sudden cardiac death It is likely that this problem has already re sulted in one patient s death In other cases de vice malf
41. ons of the device will cause the pro duction of acoustic sounds and the battery will dis charge quickly If the function Magnet use avail able is programmed OFF and the mode change with a magnet is blocked in the close position the device will continue to deliver the brady and tachy therapies as programmed in this situation the available device lifetime will be significantly reduced and the time between ERI and EOL could be reduced The recommendations suggested by the man ufacturers for the management of patient are the following e To program Magnet Use Available on OFF With this program e The magnet will not inhibit the therapy e The Triggered Monitor function of the pa tients is available e With the programmer it is possible to tem porarily block the tachy therapy e Toavoid the use ofa magnet where possible e Ifan acoustic signal comes from the device the patients should contact the referral center for urgent device interrogation PACE Vol 29 ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participatin
42. r near syncope 2 The patient has received appropriate therapy for VT or VF whether the device was implanted for secondary or primary preven tion 3 The patient is pacemaker dependent The risk analysis should be explained to the patient including the risks associated with device replacement 656 June 2006 B an individual analysis be performed for patients with potentially affected devices and sug gest follow up at least every 3 months or device replacement when 1 the indication for device implantation was primary prevention but the patient has not required therapy for VT or VF 2 the indication for device implantation was secondary prevention for VT not associ ated with syncope cardiopulmonary resusci tation or electrical cardioversion and with left ventricular ejection fraction LVEF gt 35 3 the patient received appropriate ATP therapy and no shock therapy for hemody namically well tolerated VT and does not have a history of poorly tolerated VT or VF 4 sinus bradycardia and or 2nd 3rd degree heart block with satisfactory escape rhythm heart rate over 40 beats min When in the judgment of the responsible physician it is felt that prophylactic replacement should be undertaken ECAS believes that the man ufacturer must provide a replacement device at no charge and reimburse related medical expenses The risk analysis should be explained to the pa tient including the risks associated with device re plac
43. re August 1 2003 should be considered for a prophylactic replace ment of the pacemaker e For those patients who have received a pacemaker manufactured after August 1 2003 as no failures have been reported and consider ing that the risks of pacemaker replacement are greater than the mean percentage of all pacemakers failures circa 0 15 per year the manufacturer does not recommend the replacement of these devices ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participating in the global surveil lance of the performance of these devices by making returns to national and or international audit bodies The Society has considered the information provided by ELA Medical and notes the very low incidence of malfunction reported and the absence of life threatening patient injury Recognizing that because of underreporting the risk rate may be greater than that currently noted we encourage all colleagues to report to ECAS the manufacturer and relevant regulatory authorities any further cases that have been iden tified or become apparent Even
44. re made by Medtronic e Because of the low probability of a life threatening event in this patient population Medtronic does not recommend the replacement of these devices before the ERI battery level is reached e To continue the follow up routine accord ing to clinical practice with visits at least every 6 months and to educate patients to seek medical aid if dizziness or syncope occur e To determine if device replacement is nec essary by evaluating each individual case and to inform the patient of the situation making sure that the patient is aware of the risks associated with re placement of the device In case of prophylactic replacement in high risk patients the manufacturer will provide a re placement device at no charge as actual guarantee rules state ECAS Committee Statement and Recommendations Consistent with its principle of main taining the highest standards of patient care ECAS supports the recommendation that ev ery device center must maintain an up to date record of all implanted devices includ ing serial numbers and implant dates so that those at risk can be identified This respon sibility includes undertaking enhanced follow up according to current recommendations and participating in the global surveillance of the performance of these devices by making re turns to national and or international audit bodies The Society has considered the information provided by Medtronic and notes the very low
45. red for pro phylactic device replacement or a stricter follow up i e For patients implanted with the second group of devices although the incidence of the fault is very low 2 of 1 856 devices ELA will con tinue to monitor the occurrence of the fault and will furnish information about its incidence and any significant change in its occurrence ELA rec ommend a follow up visit every 3 months in ac cordance with the recommendations reported in the user manual PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILURES AND COMPLICATIONS ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be identi fied This responsibility includes undertaking en hanced follow up according to current recommen dations and participating in the global surveillance of the performance of these devices by making re turns to national and or international audit bodies The Society has considered the information and recommendations provided by ELA Medical The reported incidence of device malfunction in the first group of devices April to July 2003 of 2 6 is too high and it is not acceptable for high risk patients In consideration of the absence of criteria for battery discharge prediction
46. ted VT with LVEF gt 35 and does not have a history of poorly tolerated VT or VF 4 sinus bradycardia and or 2nd 3rd degree heart block with satisfactory escape rhythm heart rate over 40 beats min After an individual analysis of each patient more conservative management could be appro priate for patients in the second group August 2003 to August 2004 where the fault s incidence is 0 1 2 malfunctions over 1 856 devices ob serving a follow up visit every three 3 months and considering a prophylactic device replacement for high risk patients Every pacemaker and ICD center should ask ELA Medical for the complete list of implanted devices with serial number and implant data in or der to facilitate the follow up and to enable global surveillance on devices lost to follow up Every center should report to ECAS new cases of malfunction in order to perform the best moni toring In case of prophylactic replacement in high risk patients ECAS believes that the manufacturer must provide a replacement device at no charge and reimburse related medical expenses Section II Pacemakers IPGs Recommendation ECAS DF IPG 01 2006 DEVICES Guidant PULSAR MAX PULSAR DISCOVERY MERIDIAN PULSAR MAX II DISCOVERY II VIRTUS PLUS II INTELIS II and CONTAK TR Background On July 18 2005 Guidant sent a letter to physicians providing important medical device safety information regarding a subset of PULSAR MAX PULSAR DISCOVERY
47. tempted device interrogation and programmer display of yellow warning screen indicating out of range shocking impedance These events occurring in isolation or in combination were observed between 11 and 45 months after implant ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participating in the global surveil lance of the performance of these devices by making returns to national and or international au dit bodies ECAS has taken note of information provided by Guidant and of the very low probability of de vice failure 0 1 However we cannot underes timate the concern this engenders for patients for whom these devices are implanted to prevent sud den death With regard to these events and while waiting for further information particularly the identifica tion of new cases or new types of failure ECAS suggests that A the device be replaced if one of the fol lowing conditions is met 1 The patient underwent device im plantation as secondary prevention following cardiac arrest or VT associated with hemody namic collapse syncope o
48. the hospital in case of any change in symptoms ECAS Committee Statement and Recommendations Consistent with its principle of maintaining the highest standards of patient care ECAS sup ports the recommendation that every device cen ter must maintain an up to date record of all implanted devices including serial numbers and implant dates so that those at risk can be iden tified This responsibility includes undertaking enhanced follow up according to current recom mendations and participating in the global surveil lance of the performance of these devices by mak ing returns to national and or international audit bodies That being stated and while waiting for new information by the manufacturer in particular regarding the identification of new malfunction cases ECAS suggests the following guidelines for the management of these patients Every patient should be informed in detail of the problem and the risk of device malfunction but pointing out the low frequency of the known risk ECAS suggests that A the device be replaced if one of the fol lowing conditions is met 1 The patient underwent device im plantation as secondary prevention following cardiac arrest or VT associated with hemody namic collapse syncope or near syncope 2 The patient has required appropriate therapy for VT or VF 3 The patient is pacemaker dependent In case of prophylactic replacement in high risk patients ECAS believes that the manufac
49. tients could suffer from symp tomatic deterioration such as syncope presyncope or heart failure in the event of sudden loss of pacing This category should include patients with atrial fibrillation and slow ventricular rate together with prolonged pauses and those with sinus node dysfunc tion and prolonged pauses The risk analysis should be explained to the patient including the risks associate with device replacement In case of entirely pro phylactic replacement in high risk patients ECAS believes that the manufacturer must provide a replacement device at no charge and reimburse related medical expenses We recommend patients be asked to sign a form indicating that they have been in formed of the risks and that they understand and agrees with the choices made In case of device replacement because of the possibility of surgical complications it is recommended that the informed consent form contains a statement indicating that the patient is aware that replacement will be per formed solely as a precautionary measure and a statement summarizing the risks and con sequences of device failure and the risks of device replacement B Individual evaluation be performed in 1 Patients with symptomatic chrono tropic incompetence where deactivating rate responsive function could induce wors ening of their clinical condition 2 Patients with sinus bradycardia and or 2nd or 3rd degree AV block to gether with good escape rhyt
50. ts in an electrical short circuit resulting in the de vice s inability to deliver therapy As of today there have been 26 reports of this failure in about 37 000 devices worldwide all manufactured prior to November 2002 This situation resulted in 25 replacements In March 2005 a malfunctioning de vice was returned after a patient died This device was found to have experienced failure in conjunc tion with the attempted delivery of at least one high voltage therapy In 2002 Guidant changed the manufacturing of the device on two differ ent occasions April and November to reduce the risk of device failure Guidant recommends that physicians continue normal monitoring for all pa tients with PRIZM 2 DR ICDs Guidant does not recommend replacement of these devices prior to the appearance of normal elective replacement indicators ERIs On June 17 2005 Guidant notified the FDA and sent safety information regarding its car dioverter defibrillators VENTAK PRIZM 2 DR The FDA has indicated that it will classify them as re calls Guidant indicated that this failure can oc cur in 26 000 devices built prior to the April 2002 change No failure has been observed in the de vices built after the April 2002 change Approxi mately 17 000 devices built before April 2002 re main in service Currently there are 28 reports of this failure Following formal request for more informa tion Guidant clarified that 1 in Italy 845 devices
51. turer must provide a replacement de vice at no charge and reimburse related med ical expenses The risk analysis should be explained to the patient including the risks associated with device replacement B that an individual analysis of each patient with a potentially affected device be performed and suggest periodic follow up every 3 months when 1 The indication for implantation was primary prevention and the patient has not required therapy for VT or VF June 2006 661 SANTINI ET AL 2 The indication for implantation was secondary prevention but only for hemody namically well tolerated VT with LVEF gt 35 and without need for cardiac resynchroniza tion or shock therapy 3 The patient received appropriate ATP therapy and no shock therapy for hemody namically well tolerated VT with LVEF gt 35 and does not have a history of poorly tolerated VT or VF 4 Sinus bradycardia and or 2nd 3rd degree heart block with satisfactory escape rhythm heart rate over 40 beats min Such individual risk assessment may indicate the need for elective device replacement in some patients The risk analysis should be explained to the patient including the risks associated with de vice replacement In case of prophylactic replace ment in high risk patients ECAS believes that the manufacturer must provide a replacement device at no charge and reimburse related medical ex penses We recommend that the patient be asked to sign a for
52. unction resulted in the failure of pacing therapy ECAS suggests that in order to ensure the highest standard of patient care the risk profile of each patient with a potentially affected de vice should be assessed individually and their device assessed in detail as recommended by Guidant With regard to these events and while waiting for further information particularly the identifica tion of new cases or new types of failure ECAS suggests that A the device be replaced if one of the fol lowing conditions is met 1 The patient underwent device im plantation as secondary prevention following 658 June 2006 cardiac arrest or VT associated with hemody namic collapse syncope or near syncope 2 The patient has required appropriate therapy for VT or VF whether the device was implanted for secondary or primary preven tion 3 The patient is pacemaker dependent In case of prophylactic replacement in high risk patients ECAS believes that the manufacturer must provide a replace ment device at no charge and reimburse related medical expenses The risk analy sis should be explained to the patient in cluding the risks associated with device replacement B that an individual analysis of each patient with a potentially affected device be performed and suggest periodic follow up every 3 months when 1 Indication for implant was primary prevention and the patient has not required therapy for VT or VF 2 Secondary pre
53. vention implant but only for hemodynamically well tolerated VT with LVEF gt 35 and without need for cardiac resynchronization or shock therapy 3 The patient has received appropriate ATP therapy and no shock therapy for hemo dynamically well tolerated VT with LVEF gt 35 and does not have a history of poorly tolerated VT or VF 4 Sinus bradycardia and or 2nd 3rd degree heart block with satisfactory escape rhythm heart rate over 40 beats min Such individual risk assessment may indicate the need for elective device replacement in some patients The risk analysis should be explained to the patient including the risks associated with de vice replacement In case of prophylactic replace ment in high risk patients ECAS believes that the manufacturer must provide a replacement de vice at no charge and reimburse related medical expenses We recommend that the patient be asked to sign a form indicating that he or she has been in formed of the risks and that he or she understands and agrees with the choices made In case of device replacement because of the possibility of surgical complications it is recom mended that the informed consent form contains a statement indicating that the patient is aware that replacement will be performed solely as a precau tionary measure and a statement summarizing the risks and consequences of device failure and the risks of device replacement PACE Vol 29 ECAS COMMITTEE ON DEVICE FAILUR
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