Product Performance Report

Transcription

1 Product Performance Report Cardiac Rhythm Management April 7

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3 Letter from St. Jude Medical APRIL 7 As world leaders in the development of state-of-the-art technology for cardiac rhythm management (CRM) devices, St. Jude Medical appreciates that our products are implanted in people whose health and wellbeing depend on their performance. From product design through patient follow-up, St. Jude Medical employees are dedicated to product quality and patient safety. In keeping with this commitment, we publish a product performance report semi-annually to keep the healthcare community and the patients it serves informed of the overall performance of our cardiac devices, which include implantable cardioverter defibrillators (ICDs), pacemakers and implantable pacing and defibrillation leads. St. Jude Medical also recognizes the value of the industry working together to provide transparent and consistent information on the performance of CRM products. Following the 5 Policy Conference on Pacemaker and ICD Device Performance, cardiac device companies have worked together through AdvaMed to establish a proposal for Requirements for Uniform Reporting of Clinical Performance of Pulse Generators. This proposal, which St. Jude Medical has adopted, sets forth the definitions and requirements for product performance reports and seeks to provide physicians and their patients with a level of device performance information that is consistent across manufacturers. As a result of this cooperation with AdvaMed and other cardiac device companies, St. Jude Medical has further modified its product performance report as described on the following pages. As we continually strive to provide transparent and consistent information on the performance of our products, we are pleased to release this product performance report with the latest performance information on our ICDs, pacemakers and lead systems. Sincerely, Ben Khosravi Executive Vice President Technology Program Management, Quality & Leads Business Unit

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5 Table of Contents Introduction and OVERVIEW 5 CARDIAC RESYNCHRONIZATION THERAPY CRT ICDs Summary Information Battery Longevity Pulse Generators Summary Information 8 Left Heart Leads Laboratory Analysis ICDs DUAL CHAMBER Summary Information 8 Battery Longevity 5 SINGLE CHAMBER 5 Summary Information 6 Battery Longevity 6 DEFIBRILLATION LEADS 66 Laboratory Analysis 7 PULSE GENERATORS DUAL CHAMBER 7 Summary Information 96 SINGLE CHAMBER Summary Information 6 PACING LEADS BIPOLAR UNIPOLAR 5 Laboratory Analysis 8 ADVISORIES AND SAFETY ALERTS INDEX 8

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7 Introduction and Overview Serving our mission St. Jude Medical s mission is to make life better through excellence in medical device technology and services. Toward that effort, we maintain a rigorous approach to ensuring the quality of our products. The key elements of this effort include: Compliance with U.S. and international quality system standards, such as the U.S. FDA Quality Systems Regulation ( CFR Part 8) and ISO 85 (an international standard for the Quality Management System for medical devices); Thorough evaluation of product design, including extensive design verification and validation, as well as product qualification testing; Rigorous control of the design and manufacturing processes; Inspection and qualification of externally supplied components and materials; Timely analysis of returned products, including extensive malfunction investigation; Extensive internal auditing; and Continuous improvement programs. What you ll find in this report For all ICDs starting with Photon Micro and for all pacemakers starting with Affinity, you will find the analysis of data, according to the AdvaMed guidelines, collected through December, 6, including: A graph of survival probability that reflects reasons for device removal (including normal battery depletion, malfunction with compromised therapy, and malfunction without compromised therapy). It includes non-returned devices removed from service for battery depletion with no associated complaint as normal battery depletions; A graph of survival probability that excludes normal battery depletion in the Analysis; A table that accompanies and summarizes the data in each graph; and An update to Advisories starting in. Additional tables for ICDs starting with Photon Micro and pacemakers starting with Affinity that aggregate and summarize the data in the report can be found on pages for Cardiac Resynchronization Therapy (CRT) ICDs, for CRT-Pulse Generators page 8, for ICDs pages 8 and 6 and for Pulse Generators pages 96 and 6. 5

8 For ICDs prior to Photon Micro and pacemakers prior to Affinity, you will find analysis of the data collected through December, 6, consistent with previous product performance reports. These device models include: ICDs Photon DR V-HV Profile V-86F, V-86HV Contour MD V-75, V-75AC, V-75B, V-75C, V-75D Contour II V-85, V-85AC, V-85B, V-85C, V-85D Pulse Generators (Pacemakers) Meta DDDR 56D Tempo D 9 Tempo DR Meta DDDR 56 Trilogy DC+ 8 Trilogy DR+ 6, 6 Trilogy DR 5 Paragon III,, 5 Paragon II 6 Paragon,, Synchrony III 8, 9 Synchrony II, AddVent 6 Microny 5T, 55T, 55K Regency SC+ L, L Tempo V Tempo VR 9 Trilogy SR+ 6, 6 Trilogy SR 5 Solus II 6, 7 Solus, Phoenix III, 5 Phoenix 5, 8, 9 For all CRT leads, Defibrillation leads, and Pacing leads, you will find analysis of the data collected through December, 6. Laboratory analysis of the most recently released CRT leads, defibrillation leads, and pacing leads returned from the U.S. market is summarized by model. The laboratory analysis results are categorized into one of the following three categories: Implant damage - obvious damage incurred at the time of attempted implant, including but not limited to insulation cuts and damage, helix overtorque, and stylet perforation. Electrical failure - a disruption in the insulation or conductors resulting in compromised electrical performance. Other - includes other sources of malfunction not attributed to damage incurred at the attempted implant and not resulting in compromised electrical failures. This category also includes any partial leads returned with an alleged malfunction even if it was not possible to perform analysis to confirm the malfunction. 6

9 Introduction and Overview Older lead models for which survival charts are presented consistent with previous product performance reports include: Defibrillation Leads TVL ADX 559 SPL SP, SP, SP, SP TVL RV RV, RV, RV, RV6, RV7 TVL SVC SV, SV, SV Pacing Leads Tendril 8, 88T Tendril DX 88T/TC Fast-Pass 8T, 8T Passive Plus 6T, T, 6T, T, 6T, 6T, T, 6T Passive Plus DX 6T, T, 6T Permathane ACE 6T, 8T Tendril 88K Tendril DX 88K Fast-Pass 7 Passive Plus 5K, K, 5K, 5K, K, 5K Passive Plus DX K, 5K Permathane ACE 5M ACE 5M, 5M, 6T We have also included a summary of the methods used for measuring product performance and a summary of the definitions for key terms used in preparing the report. What s new in this report Starting with this version of the St. Jude Medical Product Performance Report, a summary description section has been added to each survival chart, as identified below: ICDs and Pulse Generators (Pacemakers) US Market Release Date Registered Number of US Implants Estimated Number of Active US Implants Estimated Longevity in years Number of Normal Battery Depletions Number of Malfunctions (including returns related to Advisories) Number of Advisories Maximum Delivered Energy in joules (ICDs only) For the CRT ICD, ICD, and Pulse Generator (Pacemaker) tabulated data, the following data has been added: Number of Returns with Malfunction due to Premature Battery Depletion 7

10 Leads US Market Release Date Registered Number of US Implants Estimated Number of Active US Implants Lead Type and/or Fixation Polarity Steroid Number of Advisories Laboratory Analysis Results (for the most recent market released models) Additionally, the method to calculate leads survival has been revised to only include lead complications (returns and complaints not returned) with implant duration greater than days. Lead complications under days are not considered to be related to a lead malfunction and are therefore excluded from the survival calculations, consistent with industry practice. Methodology For devices that are implanted in the body and have a service life of several years, measuring performance presents a number of considerations for medical device manufacturers. St. Jude Medical encourages that all products, once they are taken out of a patient for any reason, be returned for analysis. There are some situations where those devices are not always returned. These include, for example, pacing and defibrillation leads that are not routinely explanted due to the risk to patients of explanting these devices. The industry standard method of evaluating product performance is survival analysis, which estimates the probability that a device will not malfunction during a specified period of time. This statistical method best represents device performance in general over a specified period of time. 8

11 Introduction and Overview How St. Jude Medical measures product performance For ICDs, pacemakers and leads, we compile cumulative survival data based on the actuarial (or life-table) method of survival analysis. Product performance is plotted over a maximum of years, with a minimum of 5 registered implants required for inclusion in the report, and a minimum sample size for each time period of devices. The data for the analysis covers all documented implants in the United States, and includes the analysis of all domestically implanted pulse generators returned to St. Jude Medical. The analysis measures device performance to specification, and does not reflect medical complications such as infection, erosion, muscle stimulation or inhibition, or units implanted for fewer than hours. Survival refers to the proper function of the device, not the survival of the patient, and is intended to illustrate the calculated probability of device survival at a given point in time. A survival probability of 99% at five years, for example, indicates that at five years after implant, the system has a % risk of incurring a malfunction and/or normal battery depletion. All devices within each model family (except where noted) are included in the calculations. St. Jude Medical lead analysis includes all leads returned to the company, as well as those registered as complaints but not returned. This method is used to ensure a conservative failure estimate for lead performance. At the time of this report, St. Jude Medical is not using data from leads registry studies. Implanted cardiac leads are subjected to constant, complex flexural and torsional forces, interactions with other leads and/or the pulse generator device, plus other forces associated with cardiac contractions and patient physical activity, posture, and anatomical influences. As such, cardiac leads functional lifetimes are therefore limited and indeed, their functional longevity can not be predicted. Because of the large size of the U.S. data pool, and because in general the same products are used both in the U.S. and internationally, we consider the data in this report to be accurately representative of each device s performance, regardless of where in the world it was implanted. 9

12 Medical Advisory Board Review St. Jude Medical has established separate device and leads medical advisory boards (MABs) to review the performance data contained in this report prior to its release and publication on a semi-annual basis. MAB members and their location of practice include: Devices Dr. Steven Bailin, Des Moines, Iowa Dr. Jim Baker, Nashville, Tennessee Dr. Anne Curtis, Tampa, Florida Dr. Steve Greenberg, Roslyn, New York Dr. Thomas Mattioni, Phoenix, Arizona Dr. Gery Tomassoni, Lexington, Kentucky Leads Dr. Christopher Fellows, Seattle, Washington Dr. Roger Freedman, Salt Lake City, Utah Dr. David Hayes, Rochester, Minnesota Dr. Steven Kalbfleisch, Columbus, Ohio Dr. Steven Kutalek, Philadelphia, Pennsylvania Dr. Raymond Schaerf, Burbank, California Dr. Bruce Wilkoff, Cleveland, Ohio Returning Devices to St. Jude Medical To maintain the continued accuracy of our performance reporting, we encourage physicians to notify our Patient Records department each time a device is removed from service as a result of device replacement or patient death. Our Patient Records department can be reached at 888-SJM-CRMD or All explanted devices should be returned for evaluation. St. Jude Medical will provide upon request a Returned Products Kit comprised of a postage paid explant box with a shipping address label, a Removed Device Information (RDI) form, a biohazard bag, and biohazard labels to seal the explant box. This kit, order #N, can be ordered at no charge through St. Jude Medical Customer Service by any of the following means: Call SJM CRM Customer Service at Fax SJM CRM Customer Service at SJM CRM Customer Service at lit@sjm.com In addition, we are always ready to respond to questions, comments or suggestions. You can reach us by phone at 888-SJM-CRMD, or on the web at

13 Introduction and Overview Definitions The following definitions have been used in preparing this report. Where applicable, the asterisk denotes definitions taken verbatim or based on AdvaMed Proposal definitions. Estimated Active Implants - The total number of registered implants of a device, adjusted to reduce the bias attributable to the potential underreporting of: Devices removed from service due to malfunction; Devices removed from service while in specification, such as devices removed due to changes in patient condition; Devices removed from service due to patient death; and Devices removed from service due to normal battery depletion. In St. Jude Medical s product performance reports, additional adjustments have been made to account for potential underreporting of patient deaths and devices removed from service due to battery depletion. For underreporting of devices removed from service due to battery depletion, in addition to returned product, we have also included product that has not been returned in the total count of normal battery depletion. By doing this, we see a steeper decline in the all cause survival probabilities in the latter years of the device life due to normal battery depletion. For example, approximately 85% of St. Jude Medical pacemakers are expected to survive up to their estimated longevity based on.5 V pacing output, % DDD pacing, 5 ohms lead impedance, stored EGMs Off, and AutoCapture Off. Also, we have revised our definition of normal battery depletion to 75% of estimated longevity, consistent with the AdvaMed proposal and other product performance reports in our industry. Estimated Longevity - The estimated number of years in which a device is expected to reach its Elective Replacement Indicator (ERI), as stated in the product user s manual. The estimate is based on battery life approximations, and is affected by many factors such as programmed parameters, percentage of time paced, internal impedance, use of AutoCapture, etc. For example, Identity pacemaker model 586 has an estimated longevity of 6.9 years based on.5 V pacing output, % DDD pacing, 5 ohms lead impedance, stored EGMs Off, and AutoCapture Off. Malfunction - Having characteristics that are outside the performance limits established by the manufacturer while implanted and in service, as confirmed by laboratory analysis, except changes to characteristics due to normal battery depletion or induced malfunction. Device damage caused after or during explant is not considered a malfunction.*

14 Malfunction with Compromised Therapy - The condition when a device is found to have malfunctioned, as defined above, in a manner that compromised pacing or defibrillation therapy (including complete loss or partial degradation) while implanted and in service. Therapy is considered to have been compromised if no therapy is available or critical patient-protective pacing or defibrillation therapy is not available.* (A malfunction with compromised therapy does not imply that a patient has actually experienced a serious complication or death as a result of the malfunction although it does imply that the potential for a serious complication or death did exist during the period of the malfunction.) Malfunction without Compromised Therapy - The condition when a device is found to have malfunctioned, as defined above, in a manner that did not compromise pacing or defibrillation therapy while implanted and in service, as confirmed by laboratory analysis. Therapy is not compromised as long as the critical patient-protective pacing and defibrillation therapies are available. Changes in device setting that occur as intended by the design (for example, reversion to a designed Safe Mode or Power-On Reset [POR]) that do not result in loss of critical patient protective therapies but are the reported reasons for explant shall be categorized as a Malfunction without Compromised Therapy.* Normal Battery Depletion - The condition where a returned device met its electrical specification and reached its elective replacement indicator voltage: with implant duration meeting or exceeding the nominal predicted longevity at default shipped settings,* or with an implant duration exceeding 75% of its estimated longevity, based on the longevity calculation tool using information from device usage and the actual device settings.* A device that does not exceed 75% of its estimated longevity would be considered a premature battery depletion malfunction (either with or without compromised therapy), provided that actual device setting information is available. *AdvaMed Proposal - Requirements for Uniform Reporting of Clinical Performance of Pulse Generators.

15 Cardiac Resynchronization Therapy CRT ICDs

16 Cardiac Resynchronization Therapy Epic II HF (Model V-55) US Market Release May 6 Registered US Implants Estimated Active US Implants Estimated Longevity (see table on page ) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at 8 months.%.% % Excluding Normal Battery Depletion 8% 6% % % % 5 at 8 months.%.%

17 CRT ICDs Epic HF (Model V-8) US Market Release June Registered US Implants,8 Estimated Active US Implants,78 Estimated Longevity (see table on page ) Max. Delivered Energy joules Normal Battery Depletion 55 Malfunctions 6 Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at 8 months 99.9% 99.% 9.95% 9.7%.6%.%.96%.9% 8 9 % Excluding Normal Battery Depletion 8% 6% % % % 5 at 8 months 99.9% 99.89% 99.% 99.%.5%.7%.%.8% 5

18 Cardiac Resynchronization Therapy Epic HF (Model V-7) US Market Release November Registered US Implants, Estimated Active US Implants,68 Estimated Longevity (see table on page ) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % %.% 5 at months 99.96%.% 8 Excluding Normal Battery Depletion % 8% 6% % % % 5.%.% at months.%.% 6

19 CRT ICDs Atlas II HF (Model V-65) US Market Release August 6 Registered US Implants 978 Estimated Active US Implants 97 Estimated Longevity (see table on page ) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at months.%.% 5 % Excluding Normal Battery Depletion 8% 6% % % % 5 at months.%.% 7

20 Cardiac Resynchronization Therapy Atlas + HF (Model V-) US Market Release June Registered US Implants,898 Estimated Active US Implants,5 Estimated Longevity (see table on page ) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at months 99.89% 99.5% 99.7%.%.%.5% 89 9 Excluding Normal Battery Depletion % 8% 6% % % % 5 at months 99.9% 99.9% 99.9%.%.5%.5% 8

21 CRT ICDs Atlas + HF (Model V-) US Market Release November Registered US Implants,89 Estimated Active US Implants,57 Estimated Longevity (see table on page ) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions 7 Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % %.% 99.86%.6% 6 % Excluding Normal Battery Depletion 8% 6% % % % %.% 99.88%.5% 9

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23 Summary Information Cardiac Resynchronization Therapy CRT ICDs

24 Cardiac Resynchronization Therapy CRT ICDs Including Normal Battery Depletion Summary Information* Models V-55 Family Epic II HF US Market Release Date May 6 Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy Malfunctions w/ Compromised Therapy (premature battery depletion) Malfunctions w/o Compromised Therapy Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions Total Normal Battery Depletion ** year year year V-8 Epic HF June % 99.% 9.95% V-7 Epic HF November % V-65 Atlas II HF August V- Atlas + HF June % 99.5% V- Atlas + HF November % 99.86% Excluding Normal Battery Depletion Summary Information* Models Family US Market Release Date Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy Malfunctions w/ Compromised Therapy (premature battery depletion) Malfunctions w/o Compromised Therapy Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions ** year year year V-55 Epic II HF May 6 V-8 Epic HF June % 99.89% 99.% V-7 Epic HF November 68.% V-65 Atlas II HF August V- Atlas + HF June % 99.9% V- Atlas + HF November % 99.88% Battery Longevity Approximate Duration (years) Models Family No Pacing 5% Pacing 5% Pacing % Pacing V-55 Epic II HF V-8, V-7 Epic HF, serial numbers < Epic HF, serial numbers > V-65 Atlas II HF V- Atlas + HF V- Atlas + HF * Based on returned product analysis as of December, 6. ** No survival probability is stated at one year due to the device not meeting the required minimum sample size of U.S. implants with consecutive months of data. Please refer to the individual device graphs for data up to one year. Battery longevity calculated with one EGM storage. Pacing parameters: DDD,.5V,.5 ms, 6 ppm, 5 ohms Battery Voltage Range:..5; Battery condition: Normal Four maximum charges per year. (See the reference manuals for more information.)

25 Cardiac Resynchronization Therapy Pulse Generators

26 Cardiac Resynchronization Therapy Frontier (Model 558) US Market Release May Registered US Implants 7 Estimated Active US Implants Estimated Longevity 5.9 s Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at 5 months.% 99.% 99.%.%.57%.57% 7 % Excluding Normal Battery Depletion 8% 6% % % % 5 at 5 months.%.%.%.%.%.%

27 pulse generators Frontier II (Model 5586) US Market Release August Registered US Implants,86 Estimated Active US Implants,69 Estimated Longevity 6.5 s Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at 9 months 99.79% 99.79% 99.79%.5%.5%.5% 7 % Excluding Normal Battery Depletion 8% 6% % % % 5 at 9 months 99.79% 99.79% 99.79%.5%.5%.5% 5

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29 Summary Information Cardiac Resynchronization Therapy Pulse Generators

30 Cardiac Resynchronization Therapy pulse generators Including Normal Battery Depletion Summary Information* Models Family US Market Release Date Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions Total Normal Battery Depletion year year year 558 Frontier May 7.% 99.% 5586 Frontier II August % 99.79% Excluding Normal Battery Depletion Summary Information* Models Family US Market Release Date Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions year year year 558 Frontier May 7.%.% 5586 Frontier II August % 99.79% *Based on returned product analysis as of December, 6. 8

31 Cardiac Resynchronization Therapy Left Heart Leads

32 Cardiac Resynchronization Therapy QuickSite (Model 56K) Laboratory Analysis: Implant Damage: 8 Electrical Malfunction: Other: 68 US Market Release June Type and/or Fixation S-Curve Registered US Implants 6,5 Polarity Unipolar Estimated Active US Implants 5, Steroid Yes Number of Advisories None % 8% 6% % % % 5 at months 99.% 98.6% 98.6%.%.6%.6% 6 9 QuickSite (Model 56T) Laboratory Analysis: Implant Damage: 59 Electrical Malfunction: Other: 5 US Market Release April 5 Type and/or Fixation S-Curve Registered US Implants 7,5 Polarity Bipolar Estimated Active US Implants 5,9 Steroid Yes Number of Advisories None % 8% 6% % % % 5 99.%.9% 5 at months 98.9%.%

33 Left Heart Leads QuickSite (Model 58T) Laboratory Analysis: Implant Damage: 6 Electrical Malfunction: Other: US Market Release February 6 Registered US Implants,69 Estimated Active US Implants, Type and/or Fixation Polarity Steroid Number of Advisories S-Curve Bipolar Yes None % 8% 6% % % % 5 at 6 months.%.% 7

34 Cardiac Resynchronization Therapy Left Heart Leads Laboratory Analysis* Estimated US Market Registered Active Implant Electrical Models Release Date US Implants US Implants Damage Malfunctions Other 56K June T April T February Laboratory analysis of all returned leads from the U.S. is summarized by model for the most recently market released cardiac resynchronization therapy (CRT) lead models included in this Product Performance Report. The Laboratory analysis results are categorized into one of the following three categories: Implant Damage - Obvious damage incurred at the time of implant, including but not limited to insulation cuts and damage, helix overtorque, and stylet perforation. Electrical Malfunction - A disruption in the insulation or conductors resulting in compromised electrical performance. Other - Includes other sources of malfunction not attributed to damage incurred at implant and not resulting in compromised electrical failures. This category also includes any partial leads returned with an alleged malfunction even if it was not possible to perform analysis to confirm the malfunction. *Based on returned product analysis as of December, 6.

35 ICDs Dual-Chamber

36 ICDs Atlas II DR (Model V-65) US Market Release August 6 Registered US Implants 8 Estimated Active US Implants 5 Estimated Longevity (see table on page 5) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at month.%.% % Excluding Normal Battery Depletion 8% 6% % % % 5 at month.%.%

37 dual-chamber Atlas II DR (Model V-68) US Market Release August 6 Registered US Implants,78 Estimated Active US Implants,7 Estimated Longevity (see table on page 5) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at months.%.% 5 % Excluding Normal Battery Depletion 8% 6% % % % 5 at months.%.% 5

38 ICDs Atlas DR (Model V-) US Market Release October Registered US Implants,6 Estimated Active US Implants,77 Estimated Longevity (see table on page 5) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at months 99.9% 99.86% 99.86%.5%.8%.8% 5 6 % Excluding Normal Battery Depletion 8% 6% % % % 5 at months.% 99.9% 99.9%.%.7%.7% 6

39 dual-chamber Atlas + DR (Model V-) US Market Release October Registered US Implants 7,9 Estimated Active US Implants 5,78 Estimated Longevity (see table on page 5) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at 5 months 99.97% 99.9% 99.9%.%.%.% 57 % Excluding Normal Battery Depletion 8% 6% % % % 5 at 5 months 99.98% 99.97% 99.97%.%.%.% 7

40 ICDs Epic II DR (Model V-58) US Market Release May 6 Registered US Implants 7 Estimated Active US Implants 65 Estimated Longevity (see table on page 5) Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Max. Delivered Energy joules Number of Advisories None Including Normal Battery Depletion % 8% 6% % % % 5 at months.%.% Excluding Normal Battery Depletion % 8% 6% % % % 5 at months.%.% 8

41 dual-chamber Epic + DR (Model V-6) US Market Release April Registered US Implants, Estimated Active US Implants,75 Estimated Longevity (see table on page 5) Max. Delivered Energy joules Normal Battery Depletion 7 Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at months 99.9% 99.8% 99.69% 99.6%.8%.8%.%.% 5 % Excluding Normal Battery Depletion 8% 6% % % % 5 at months 99.96% 99.96% 99.96% 99.96%.%.%.%.% 9

42 ICDs Epic + DR (Model V-9) US Market Release October Registered US Implants 6,9 Estimated Active US Implants 6,6 Estimated Longevity (see table on page 5) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % 5 at months 99.95% 99.95% 99.95%.%.%.% % Excluding Normal Battery Depletion 8% 6% % % % 5 at months 99.95% 99.95% 99.95%.%.%.%

43 dual-chamber Epic DR (Model V-5) US Market Release July Registered US Implants 6,567 Estimated Active US Implants,77 Estimated Longevity (see table on page 5) Max. Delivered Energy joules Normal Battery Depletion Malfunctions 9 Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) 6 Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % 5 at 9 months 99.95% 99.88% 99.8% 99.5% 99.5%.%.5%.%.6%.6% % Excluding Normal Battery Depletion 8% 6% % % % 5 at 9 months 99.95% 99.9% 99.89% 99.75% 99.75%.%.%.5%.9%.9%

44 ICDs Epic DR (Model V-) US Market Release October Registered US Implants,75 Estimated Active US Implants,6 Estimated Longevity (see table on page 5) Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Max. Delivered Energy joules Number of Advisories (see pages -6) One Including Normal Battery Depletion % 8% 6% % % % 5 at 5 months.%.%.%.%.%.% 5 7 Excluding Normal Battery Depletion % 8% 6% % % % 5 at 5 months.%.%.%.%.%.%

45 dual-chamber Atlas DR (Model V-) US Market Release December Registered US Implants 8,8 Estimated Active US Implants,59 Estimated Longevity (see table on page 5) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions 7 Malfunctions w/ Compromised Therapy ( related to Advisory) 8 Malfunctions w/o Compromised Therapy ( related to Advisory) 9 Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % 5 at 57 months 99.8% 99.9% 97.68% 9.% 85.68%.%.8%.8%.%.8% % Excluding Normal Battery Depletion 8% 6% % % % 5 at 57 months 99.88% 99.78% 99.5% 99.% 99.5%.%.5%.8%.%.6%

46 ICDs Photon µ DR (Model V-) US Market Release June Registered US Implants, Estimated Active US Implants 9 Estimated Longevity (see table on page 5) Max. Delivered Energy 6 joules Normal Battery Depletion 96 Malfunctions Malfunctions w/ Compromised Therapy ( related to Advisory) 6 Malfunctions w/o Compromised Therapy ( related to Advisory) 7 Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % at 6 months 99.7% 99.8% 95.9% 85.7% 75.8% 75.7%.9%.6%.7%.75%.9%.% 7 % Excluding Normal Battery Depletion 8% 6% % % % at 6 months 99.8% 99.7% 99.7% 98.76% 98.% 98.%.7%.9%.%.%.%.%

47 dual-chamber Photon DR (Model V-HV) US Market Release October Registered US Implants,88 Estimated Active US Implants Estimated Longevity (see table on page 5) Number of Advisories (see pages -6) One % 8% 6% % % % s After Implant at 68 months 99.66% 96.5% 78.% 5.8% 8.5% 7.79%.%.%.8%.7%.6%.8%

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49 Summary & Longevity Information ICDs Dual-Chamber

50 ICDs Including Normal Battery Depletion Summary Information* Models V-65 V-68 V- V- V-58 V-6 V-9 V-5 V- V- V- Family Atlas II DR Atlas II DR Atlas DR Atlas + DR Epic II DR Epic + DR Epic + DR Epic DR Epic DR Atlas DR Photon µ DR US Market Release Date August 6 August 6 October October May 6 April October July October December June Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy 8 6 Malfunctions w/ Compromised Therapy (under advisory) Malfunctions w/ Compromised Therapy (premature battery depletion) Malfunctions w/o Compromised Therapy 5 6 Malfunctions w/o Compromised Therapy (premature battery depletion) 9 Total Malfunctions 9 7 Total Normal Battery Depletion 7 96 Excluding Normal Battery Depletion Summary Information* Models Family US Market Release Date Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy Malfunctions w/ Compromised Therapy (under advisory) Malfunctions w/ Compromised Therapy (premature battery depletion) Malfunctions w/o Compromised Therapy Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions V-65 Atlas II DR August V-68 Atlas II DR August V- Atlas DR October 6 77 V- Atlas + DR October V-58 Epic II DR May V-6 Epic + DR April 75 V-9 Epic + DR October V-5 Epic DR July V- Epic DR October 75 6 V- Atlas DR December V- Photon µ DR June *Based on returned product analysis as of December, 6. 8

51 dual-chamber Including Normal Battery Depletion Summary Information* ** Models Family year year year year 5 year 6 year 7 year 8 year 9 year year V-65 Atlas II DR V-68 Atlas II DR V- Atlas DR 99.9% 99.86% V- Atlas + DR 99.97% 99.9% V-58 Epic II DR V-6 Epic + DR 99.9% 99.8% 99.69% V-9 Epic + DR 99.95% 99.95% V-5 Epic DR 99.95% 99.88% 99.8% 99.5% V- Epic DR.%.% V- Atlas DR 99.8% 99.9% 97.68% 9.% V- Photon µ DR 99.7% 99.8% 95.9% 85.7% 75.8% Excluding Normal Battery Depletion Summary Information* ** Models Family year year year year 5 year 6 year 7 year 8 year 9 year year V-65 Atlas II DR V-68 Atlas II DR V- Atlas DR.% 99.9% V- Atlas + DR 99.98% 99.97% V-58 Epic II DR V-6 Epic + DR 99.96% 99.96% 99.96% V-9 Epic + DR 99.95% 99.95% V-5 Epic DR 99.95% 99.9% 99.89% 99.75% V- Epic DR.%.% V- Atlas DR 99.9% 99.78% 99.5% 99.% V- Photon µ DR 99.8% 99.7% 99.7% 98.76% 98.% *Based on returned product analysis as of December, 6. ** No survival probability is stated at one year due to the device not meeting the required minimum sample size of U.S. implants with consecutive months of data. Please refer to the individual device graphs for data up to one year. 9

52 ICDs dual-chamber Battery Longevity Approximate Duration (years)* Models Family No Pacing 5% Pacing 5% Pacing % Pacing V-65 Atlas II DR V-68 Atlas II V- Atlas DR V- Atlas + DR V-58 Epic II V-6 Epic + DR V-9 Epic + DR V-5 Epic DR V- Epic DR V- Atlas DR V- Photon µ DR V-HV Photon DR * Battery longevity calculated with one EGM storage. Pacing parameters: DDD,.5V,.5 ms, 6 ppm, 5 ohms Battery Voltage Range:..5; Battery condition: Normal Four maximum charges per year. (See the reference manuals for more information.) 5

53 ICDs Single-Chamber

54 ICDs Atlas II VR (Model V-68) US Market Release August 6 Registered US Implants 65 Estimated Active US Implants 65 Estimated Longevity (see table on page 6) Max. Delivered Energy 6 joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at months.%.% % Excluding Normal Battery Depletion 8% 6% % % % 5 at months.%.% 5

55 single-chamber Atlas + VR (Model V-9) US Market Release October Registered US Implants 6,58 Estimated Active US Implants 5,88 Estimated Longevity (see table on page 6) Max. Delivered Energy 6 joules Normal Battery Depletion 8 Malfunctions 7 Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at 5 months 99.9% 99.87% 99.77%.%.%.% 5 % Excluding Normal Battery Depletion 8% 6% % % % 5 at 5 months 99.96% 99.9% 99.9%.%.%.% 5

56 ICDs Epic II VR (Model V-58) US Market Release May 6 Registered US Implants 6 Estimated Active US Implants 5 Estimated Longevity (see table on page 6) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy Malfunctions w/o Compromised Therapy Number of Advisories None % Including Normal Battery Depletion 8% 6% % % % 5 at month.%.% % Excluding Normal Battery Depletion 8% 6% % % % 5 at month.%.% 5

57 single-chamber Epic + VR (Model V-96) US Market Release April Registered US Implants 7,8 Estimated Active US Implants 6,56 Estimated Longevity (see table on page 6) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy ( related to Advisory) Malfunctions w/o Compromised Therapy Number of Advisories (see pages -6) Two % Including Normal Battery Depletion 8% 6% % % % 5 at 9 months 99.95% 99.9% 99.9% 99.9%.%.6%.6%.6% 6 8 % Excluding Normal Battery Depletion 8% 6% % % % 5 at 9 months 99.98% 99.98% 99.98% 99.98%.%.%.%.% 55

58 ICDs Epic VR (Model V-97) US Market Release July Registered US Implants,6 Estimated Active US Implants,6 Estimated Longevity (see table on page 6) Max. Delivered Energy joules Normal Battery Depletion Malfunctions Malfunctions w/ Compromised Therapy ( related to Advisory) 5 Malfunctions w/o Compromised Therapy ( related to Advisory) 5 Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % % 99.78% 99.7% 99.%.6%.8%.9%.% 6 % Excluding Normal Battery Depletion 8% 6% % % % % 99.8% 99.78% 99.6%.%.8%.9%.% 56

59 single-chamber Atlas VR (Model V-99) US Market Release December Registered US Implants 7,78 Estimated Active US Implants, Estimated Longevity (see table on page 6) Max. Delivered Energy 6 joules Normal Battery Depletion 6 Malfunctions 9 Malfunctions w/ Compromised Therapy (9 related to Advisory) 6 Malfunctions w/o Compromised Therapy ( related to Advisory) Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % 5 at 58 months 99.7% 99.% 98.7% 97.77% 97.9%.6%.%.5%.%.% % Excluding Normal Battery Depletion 8% 6% % % % 5 at 58 months 99.79% 99.6% 99.8% 99.8% 99.%.5%.8%.%.%.6% 57

60 ICDs Photon µ VR (Model V-9) US Market Release June Registered US Implants,8 Estimated Active US Implants,86 Estimated Longevity (see table on page 6) Max. Delivered Energy 6 joules Normal Battery Depletion 6 Malfunctions Malfunctions w/ Compromised Therapy (5 related to Advisory) Malfunctions w/o Compromised Therapy ( related to Advisory) 9 Number of Advisories (see pages -6) One % Including Normal Battery Depletion 8% 6% % % % at 6 months 99.78% 99.% 98.9% 97.76% 9.9% 9.%.9%.6%.%.%.57%.78% % Excluding Normal Battery Depletion 8% 6% % % % at 6 months 99.78% 99.6% 99.% 99.6% 98.98% 98.98%.9%.%.6%.%.%.5% 58

61 single-chamber Profile (Models V-86F & V-86HV) *Population *(These models are no longer being manufactured) *US Market Release November 998 *Registered US Implants,6 *Estimated Active US Implants 6 *Estimated Longevity (see table on page 6) *Number of Advisories None ** Population **(These models are no longer being manufactured) **US Market Release November 998 **Registered US Implants,77 **Estimated Active US Implants 8 **Estimated Longevity (see table on page 6) **Number of Advisories (see pages -6) One % 8% Population * 6% Population ** % % % 6 8 Population * 6 at 76 months 96.9% 57.6% 5.7% 5.7%.7%.%.5%.5% 7 Population ** at 9 months 9.88% 6.8% 5.69%.69%.85%.86%

62 ICDs single-chamber Contour MD (Models V-75, V-75AC, V-75B, V-75C & V-75D) US Market Release October 998 Registered US Implants,95 Estimated Active US Implants 858 Estimated Longevity (see table on page 6) Number of Advisories None % 8% 6% % % % at 8 months 99.8% 95.% 69.58% 68.9%.%.6%.7%.7% 9 Contour II (Models V-85, V-85AC, V-85B, V-85C & V-85D) US Market Release February 998 Registered US Implants,67 Estimated Active US Implants 6 Estimated Longevity (see table on page 6) Number of Advisories None % 8% 6% % % % at 77 months 98.77% 95.7% 68.% 66.59%.9%.56%.9%.% 5 6

63 Summary & Longevity Information ICDs Single-Chamber

64 ICDs Including Normal Battery Depletion Summary Information* Models V-68 V-9 V-58 V-96 V-97 V-99 V-9 Family Atlas II VR Atlas + VR Epic II VR Epic + VR Epic VR Atlas VR Photon µ VR US Market Release Date August 6 October May 6 April July December June Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy 7 5 Malfunctions w/ Compromised Therapy (under advisory**) 9 5 Malfunctions w/ Compromised Therapy (premature battery depletion) Malfunctions w/o Compromised Therapy 5 9 Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions 7 9 Total Normal Battery Depletion Excluding Normal Battery Depletion Summary Information* Models Family US Market Release Date Registered US Implants Estimated Active US Implants Malfunctions w/ Compromised Therapy Malfunctions w/ Compromised Therapy (under advisory**) Malfunctions w/ Compromised Therapy (premature battery depletion) Malfunctions w/o Compromised Therapy Malfunctions w/o Compromised Therapy (premature battery depletion) Total Malfunctions V-68 Atlas II VR August V-9 Atlas + VR October V-58 Epic II VR May V-96 Epic + VR April V-97 Epic VR July V-99 Atlas VR December V-9 Photon µ VR June *Based on returned product analysis as of December, 6. ** St. Jude Medical. ICD Memory Chip Component Anomaly (advisory). October 7, 5. 6

65 single-chamber Including Normal Battery Depletion Summary Information* Models Family year year year year 5 year 6 year 7 year 8 year 9 year year V-68 Atlas II VR V-9 Atlas + VR 99.9% 99.87% V-58 Epic II VR V-96 Epic + VR 99.95% 99.9% 99.9% V-97 Epic VR 99.9% 99.78% 99.7% 99.% V-99 Atlas VR 99.7% 99.% 98.7% 97.77% V-9 Photon µ VR 99.78% 99.% 98.9% 97.76% 9.9% Excluding Normal Battery Depletion Summary Information* Models Family year year year year 5 year 6 year 7 year 8 year 9 year year V-68 Atlas II VR V-9 Atlas + VR 99.96% 99.9% V-58 Epic II VR V-96 Epic + VR 99.98% 99.98% 99.98% V-97 Epic VR 99.9% 99.8% 99.78% 99.6% V-99 Atlas VR 99.79% 99.6% 99.8% 99.8% V-9 Photon µ VR 99.78% 99.6% 99.% 99.6% 98.98% *Based on returned product analysis as of December, 6. No survival probability is stated at one year due to the device not meeting the required minimum sample size of U.S. implants with consecutive months of data. Please refer to the individual device graphs for data up to one year. 6

66 ICDs single-chamber Battery Longevity Approximate Duration (years)* Models Family No Pacing 5% Pacing 5% Pacing % Pacing V-68 Atals II VR V-9 Atlas + VR V-58 V-96 ** Epic II VR Epic + VR V-97 Epic VR V-99 Atlas VR V-9 Photon µ VR * Battery longevity calculated with one EGM storage. Pacing parameters: DDD,.5V,.5 ms, 6 ppm, 5 ohms Battery Voltage Range:..5; Battery condition: Normal Four maximum charges per year. (See the reference manuals for more information.) **Serial numbers 5 (for serial numbers <5, refer to previous User s Manual or contact Customer Service) Models Family Max charges/yr. No Pacing Maximum High Voltage Charge/Month No Pacing 5% Pacing % Pacing V-86F, V-86HV Profile 5.8 yr.. yr.. yr..7 yr. V-75, V-75AC, Contour MD 6.5 yr..8 yr.. yr..5 yr. V-75B, V-75C, V-75D V-85, V-85AC, V-85B, Contour II 6.5 yr..8 yr.. yr..5 yr. V-85C, V-85D Pacing parameters: DDD,.5V,.5 ms, 6 ppm, 5 ohms Battery Voltage Range:..55 6

67 Defibrillation Leads

68 Defibrillation Leads Riata ST (Model 7) Laboratory Analysis: Implant Damage Electrical Malfunction Other US Market Release March 6 Type and/or Fixation Single Coil, Active Registered US Implants 6 Polarity Bipolar Estimated Active US Implants Steroid Yes Number of Advisories None % 8% 6% % % % 5 at 5 months.%.% Riata ST (Models 7 & 7) Laboratory Analysis: Implant Damage 7 Electrical Malfunction Other 9 US Market Release March 6 Type and/or Fixation Dual Coil, Active Registered US Implants,97 Polarity Bipolar Estimated Active US Implants,87 Steroid Yes Number of Advisories None % 8% 6% % % % 5 at 9 months 99.95%.% 55 66

69 Riata i (Models 59 & 59) Laboratory Analysis: Implant Damage Electrical Malfunction Other US Market Release April Registered US Implants 8,5 Estimated Active US Implants 7,97 Type and/or Fixation Polarity Steroid Number of Advisories Dual Coil, Active Bipolar Yes None % 8% 6% % % % %.% %.% 5 Riata (Model 58) Laboratory Analysis: Implant Damage 9 Electrical Malfunction 6 Other 5 US Market Release March Registered US Implants,55 Estimated Active US Implants,86 Type and/or Fixation Polarity Steroid Number of Advisories Single Coil, Active Bipolar Yes None % 8% 6% % % % 5 at 8 months 99.65% 99.65% 99.65% 99.65%.%.%.%.%

70 Defibrillation Leads Riata (Models 57 & 57) Laboratory Analysis: Implant Damage Electrical Malfunction Other US Market Release March Type and/or Fixation Dual Coil, Passive Registered US Implants 8,5 Polarity Bipolar (Quadripolar) Estimated Active US Implants 7,67 Steroid Yes Number of Advisories None % 8% 6% % % % 5 at 55 months 99.8% 99.6% 99.7% 98.5% 98.%.%.8%.%.5%.7% Riata (Models 58 & 58) Laboratory Analysis: Implant Damage 8 Electrical Malfunction 68 Other 7 US Market Release March Type and/or Fixation Dual Coil, Active Registered US Implants 59,98 Polarity Bipolar (Quadripolar) Estimated Active US Implants 5,978 Steroid Yes Number of Advisories None % 8% 6% % % % 5 at 57 months 99.77% 99.56% 99.% 98.6% 98.6%.%.%.6%.%.%

71 TVL -ADX (Model 559) US Market Release November 999 Registered US Implants,569 Estimated Active US Implants,577 Type and/or Fixation Polarity Steroid Number of Advisories Single Coil, Active Bipolar Yes None % 8% 6% % % % at 8 months 99.6% 97.7% 95.87% 95.5%.%.5%.%.8% 9 SPL (Models SP, SP, SP & SP) US Market Release September 997 Registered US Implants, Estimated Active US Implants 6,68 Type and/or Fixation Polarity Steroid Number of Advisories Dual Coil, Passive Bipolar No None % 8% 6% % % % at months 98.9% 98.9% 97.% 96.76% 96.%.%.%.7%.%.%

72 Defibrillation Leads TVL RV (Models RV, RV, RV, RV6 & RV7) TVL SVC (Models SV, SV & SV) US Market Release RV, RV, SV, SV, SV May 996 Type and/or Fixation Polarity RV April 997 Steroid RV6, RV7 July Number of Advisories Registered US Implants Estimated Active US Implants RV,99 RV, SVC 8 SVC 7 Single Coil, Passive Bipolar No None % 8% SVC Models RV Models 6% % % % RV Models 6 9 at months 98.98% 97.8% 95.98% 9.8%.9%.%.6%.6% 8 9 SVC Models 6 at months 98.59% 97.68% 97.%.7%.65%.7% 6 7

73 Laboratory Analysis* Estimated US Market Registered Active Implant Electrical Models Release Date US Implants US Implants Damage Malfunctions Other 7 March 6 6 7/7 March /59 April March /57 March /58 March Laboratory analysis of all returned leads from the U.S. is summarized by model for the most recently market released defibrillation lead models included in this Product Performance Report. The Laboratory analysis results are categorized into one of the following three categories: Implant Damage - Obvious damage incurred at the time of implant, including but not limited to insulation cuts and damage, helix overtorque, and stylet perforation. Electrical Malfunction - A disruption in the insulation or conductors resulting in compromised electrical performance. Other - Includes other sources of malfunction not attributed to damage incurred at implant and not resulting in compromised electrical failures. This category also includes any partial leads returned with an alleged malfunction even if it was not possible to perform analysis to confirm the malfunction. *Based on returned product analysis as of December, 6. 7