PRODUCT PERFORMANCE REPORT · Product Performance Report November 2009 Edition Sorin Group...

CARDIAC RHYTHM MANAGEMENT Quality Assurance & Regulatory Affairs - Parc d’affaires Noveos, 4 avenue Réaumur - 92140 Clamart - France

Phone: +33 (0)1 46 01 33 33 - Fax: +33 (0)1 46 01 36 37 - www.sorin-crm.com

©2009 Sorin SpA - All Rights Reserved - November 2009 - ref: RE06600006- UK

November 2009

CARDIAC RHYTHM MANAGEMENT

PRODUCT PERFORMANCE REPORT

Product Performance Report N o v e m b e r 2 0 0 9 E d i t i o n

Contents

1 Sorin Group Commitment to Quality 5

2 Definitions and methods 6

3 Cardiac Resynchronization Therapy (CRT) 10

3.1 Cardiac Resynchronization Therapy Defibrillators (CRT-D) . . . . . . . . . . . . . . . . . . . . 10

3.1.1 Paradym CRT 8750 - sonR 8770 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

3.1.2 Ovatio CRT 6750 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.1.3 Alto 2 MSP 627 - Alto MSP 617 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

3.2 Cardiac Resynchronization Therapy Pacemakers (CRT-P) . . . . . . . . . . . . . . . . . . . . 12

3.2.1 Talent 3 MSP 353 - Talent MSP AF 343 - MSP 313 . . . . . . . . . . . . . . . . . . . . 12

3.3 Cardiac Resynchronization Therapy Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.3.1 Situs OTW UW28D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3.3.2 Situs LV UC28D - UL28D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

4 Tachycardia Therapy 15

4.1 Implantable Cardioverter Defibrillators (ICDs) . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.1.1 Ovatio DR 6550 - VR 6250 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4.1.2 Alto 2 DR 624 - VR 625 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.1.3 Alto DR 614 - VR 615 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

4.2 Defibrillation Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.2.1 Isoline 2CR5 - 2CR6 - 2CT6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

4.2.2 Swift 4041 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5 Bradycardia Therapy 19

5.1 Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.1.1 Reply DR - D - VDR - SR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

5.1.2 Symphony DR 2550 - SOLE DR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

5.1.3 Symphony D 2450 - VDR 2350 - SOLE VDR . . . . . . . . . . . . . . . . . . . . . . . 21

5.1.4 Symphony SR 2250 - SOLE SR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

5.1.5 Rhapsody DR 2510 - SR 2210 - + DR 2530 . . . . . . . . . . . . . . . . . . . . . . . . 23

5.1.6 Rhapsody D 2410 - S 2130 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

5.1.7 Talent 3 DR 253 - VDR 263 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

5.1.8 Talent II DR 233 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

5.1.9 Talent II SR 133 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

5.1.10 Talent DR 213 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28


5.1.11 Talent AF 243 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

5.1.12 Talent D 210 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

5.1.13 Talent SR 113 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

5.1.14 Brio DR 212 - DR 222 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

5.1.15 Brio D 220 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

5.1.16 Brio SR 112 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

5.1.17 Elect DR - D - VDR - SR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

5.1.18 Diapason - Elect XS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

5.1.19 Neway - NewLiving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

5.1.20 Pacemaker Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

5.2 Pacing Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

5.2.1 XFINE TX25D - TX26D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

5.2.2 Stelix II BRF24D - BRF25D - BRF26D . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

5.2.3 Stelid II BJF24D - BJF25D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

5.2.4 Stelid II BTF25D - BTF26D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

5.2.5 Stelid II UTF26D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

5.2.6 Stelix BR45D - BR46D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

5.2.7 Stelid BT45D - BT46D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

5.2.8 Stelid BS45D - BS46D . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

5.2.9 BEST mini . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

5.2.10 S200 AB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

5.2.11 S 80 JB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

5.2.12 HEPTA 4B . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

5.2.13 S 80 TB . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52

5.2.14 S 80 UTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

5.2.15 Pacing Lead Synopsis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

6 Field Safety Notices 56

6.1 Cardioverter defibrillators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

6.1.1 Alto and Alto 2, Group 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56




6.2 Pacemakers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

6.2.1 Symphony and Rhapsody, Group 1 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

6.2.2 Symphony and Rhapsody, Group 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

6.2.3 Symphony and Rhapsody: 7 units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

6.2.4 Neway DR: 45 units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

6.2.5 Programmer software version associated with Reply SR . . . . . . . . . . . . . . . . . 77

6.3 Leads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

6.3.1 Stelid BS45D: 54 units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

7 Contacts 79


Sorin Group Commitment to Quality

1 Sorin Group Commitment to Quality

Achieving excellence in the quality and safety of our products is a top priority for Sorin Group CRM.

Our devices are designed and built to save lives; therefore Sorin Group CRM strives for the highest levelsof performance and quality, and for providing timely and reliable information on device performance to physi-cians and patients.

This November Edition of Sorin Group CRM’s 2009 Product Performance Report embodies our commitmentto update the product performance information regularly and communicate it to physicians and patients. Ourperformance report is published online semi-annually at www.sorin-crm.com. This new edition includes per-formance data collected through June 30, 2009 and incorporates the latest information about the company’smost recent pacemakers, implantable cardioverter defibrillators (ICDs), cardiac resynchronization devices andleads, as well as the most recent updates about product advisories.

Because at Sorin we believe that every patient is important and should be treated equally, and because weaim at being fully transparent with our physicians and patients, Sorin CRM’s product performance report pro-vides performance data on CRM devices implanted worldwide.

In compliance with the recommendations of the Heart Rhythm Society, this report was reviewed by an inde-pendent Product Performance Review Board.

We continually seek your input to help us enhance our product performance, and we encourage you to provideyour comments and suggestions to your local representative. We also urge you to inform your local repre-sentative immediately about any indication of potential device malfunction – if this should occur – with anyof our products. Your contribution plays a key role in communicating accurate and vital product performanceinformation.

We thank you for your support.

Benoît CLINCHAMPS

Vice President, Quality Assurance and Regulatory Affairs

Sorin Group CRM 5

http://www.sorin-crm.com/


Definitions and methods

2 Definitions and methods

This November Edition of the 2009 CRM Product Performance Report presents performance and Field SafetyNotice summaries for Sorin Group’s most recent pacemakers, implantable cardioverter defibrillators (ICDs),cardiac resynchronization devices and leads.

Historically, the vast majority of Sorin Group CRM products have been marketed and used outside the US andwere released for distribution there years earlier than in the US. For this reason, Sorin Group CRM considersthat presenting worldwide data in its Product Performance Report makes physicians and regulators betterinformed, and sooner informed.

This performance report calculates cumulative survival probability using the standard actuarial methodwith confidence intervals using Greenwood’s method. This report was prepared in accordance with ISO5841-2:20001, an international standard for reporting the clinical performance of populations of pulse genera-tors or leads.

Cumulative survival probability is the estimated probability of a unit’s surviving from the time of implant tothe end of a given interval without device malfunction. This estimation includes only events confirmed bythe manufacturer’s analysis, for which records include an implant date and an event or explant date. Becausenot all devices are returned to Sorin for analysis, limitations of passive follow up are encountered. Data onsurvival from malfunction (excluding normal battery depletion) are based on returned product analysis. Sorindoes not utilize any prospective, active device follow-up to assess device survival. As such, the survival dataprobably underestimate malfunction rates.

Device malfunction occurs when a device is out of specification after implant, except because of normalbattery depletion.

Out of specification means having one or more characteristics outside the limits established by the manu-facturer for clinical use.

According to the international standard ISO 5841-2:2000, normal battery depletion occurs when a device isout of specification after implant because it has reached the point in the service life at which the manufac-turer recommends its replacement. A more detailed definition – included in the Recommendations from theHeart Rhythm Society Task Force on Device Performance Policies and Guidelines2 – states that:

Normal Battery Depletion is the condition when:

- a device is returned with no associated complaint and the device has reached its elective replacementindicator(s) with implant time that meets or exceeds the nominal (50th percentile) predicted longevityat default (labeled) settings, or

- a device is returned and the device has reached its elective replacement indicator(s) with implant timeexceeding 75% of the expected longevity using the longevity calculation tool available at the time ofproduction introduction, calculated using the device’s actual settings.

When a device is returned – and if the return is associated with a complaint – the determination of normalbattery depletion is based on returned device analysis which is using the second criterion of the above HeartRhythm Society Task Force definition. When a device is not returned, the physician’s opinion determineswhether the explant is attributed to normal battery depletion.

1International Organization for Standardization. International Standard ISO 5841-2:2000(E), Implants for surgery – Cardiac pacemak-ers – Part 2: Reporting of clinical performance of populations of pulse generators or leads. 2000; Second edition.

2Carlson MD, Wilkoff BL, Maisel WH, Ellenbogen KA, Saxon LA, Prystowsky EN, et al. Recommendations from the Heart RhythmSociety Task Force on Device Performance Policies and Guidelines. Heart Rhythm. 2006; 3(10):1250-73.

Sorin Group CRM 6



Malfunctions for any model are further separated in malfunctions with compromised therapy and malfunctionswithout compromised therapy:

Malfunction with compromised therapy is the condition when a device is confirmed through laboratoryanalysis to have malfunctioned in a manner that compromised pacing or defibrillation therapy (includingcomplete loss or partial degradation) while implanted and in service. Examples include (but are notlimited to): sudden loss of battery voltage; accelerated current drain such that low battery was notdetected before loss of therapy; sudden malfunction during defibrillation therapy resulting in abortedtherapy delivery; intermittent malfunction in which therapy is compromised while in the malfunctionstate.

Malfunction without compromised therapy is the condition when a device is confirmed through laboratoryanalysis to have malfunctioned in a manner that did not compromise pacing or defibrillation therapywhile implanted and in service. Malfunctions in which critical patient-protective pacing and defibrillationtherapies remain available are included here. Examples include (but are not limited to): error affectingdiagnostic functions, data storage; malfunction of a component that causes the battery to lose powerquickly enough to result in premature battery depletion, but slowly enough that the condition is detectedthrough normal follow-up before therapy is lost; telemetry failure.

Electrical malfunctions are specified for pacing leads within the summary table (see Pacing lead synopsis inSection 5.2.15, p. 54). An electrical malfunction occurs when a discontinuity or interruption in the conductiveor insulation materials results in compromised electrical performance of the product while implanted. Ex-amples include deterioration of conductor components, separation of joined components, or deterioration ofinsulating components, which inappropriately exposes conductive materials to body fluids. This term does notinclude: 1) obvious damage that occurs at the time of implant or explant including but not limited to insulation/ conductor cuts or other types of mishandling, 2) complications associated with a failure to heed warnings orfollow instructions included in the labelling, or 3) any leads where an alleged electrical malfunction could notbe confirmed through returned product analysis (examples: probable dislodgement, conductor isolation issueassociated with a pacemaker connection system).

Sorin Group CRM 7



Survival graphsEach survival graph shows “cumulative survival” on its Y-axis. This refers to the probability that the device willremain in the patient’s body without malfunction during the interval from the time the device is implanted upuntil the point in time shown on the X-axis. Cumulative survival graphs are presented separately for non-FieldSafety Notice and Field Safety Notice device populations (when applicable), to provide the healthcare com-munity with clinically relevant, patient-specific device performance. Each Field Safety Notice is described inthe last section (see Section 6, pp. 56-78). Here is an example of the presentation format used:

TALENT DR 213

Cutoff date: 30-Jun-2009Analysis stops at 72 monthsor < 500 active implants.

Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 639328 26558 8936 55 99.96% 99.93% 99.91% 99.89% 99.87% 99.85%

Upper confidence interval (+) 0.01% 0.02% 0.03% 0.03% 0.03% 0.04%

Lower confidence interval (-) 0.02% 0.03% 0.04% 0.04% 0.04% 0.05%

553817Devices without compromised therapy

with 95 % confidence interval, as a function of years after implantCumulative survival from malfunction (excluding normal battery depletion)

Worldwide malfunctionsDevices with compromised therapy

65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6

Years after start of exposure

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Cumulative survival from malfunction and normal battery depletionCumulative survival from malfunction

Here is a key to the information in the sample presentation above:

Talent DR 213 Model designation for device covered by each cumulative survivalgraph appears at the upper left of the corresponding graph.

Cutoff date The graph and table contain all applicable data in the manufacturer’ssales and analysis records as of the cutoff date shown at the lowerleft of the corresponding graph.

Analysis stops at 72 monthsor < 500 active implants

Cumulative survival probability is presented for device models with500 or more estimated active implants and for any devices coveredby a Field Safety Notice regardless of the number of estimated activeimplants.

Worldwide implants Number of devices of the models covered by the graph that havebeen implanted worldwide.

Sorin Group CRM 8



Estimated active implants Number of devices estimated in service worldwide at the cutoff date.Because the manufacturer collects worldwide data passively, i.e.uses returned products to assess product performance, underreport-ing could bias the analysis. To correct for this potential bias, theanalysis uses device-tracking data collected in the United States forsame or similar types of devices, to estimate the fraction of exposeddevices withdrawn each month for:

- reasons not related to the functioning of the device

- loss to follow-up

- normal battery depletion

- patient death

Estimated normal battery deple-tion

Number of devices estimated out of service worldwide due to normalbattery depletion at the cutoff date. See definition of “normal bat-tery depletion” in Section 2 on page 6. To correct for potential biasdue to underreporting of normal battery depletion worldwide, whenthe same or similar models are marketed in the United States, theanalysis uses U.S. device-tracking data to estimate the fraction ofexposed devices withdrawn each month for normal battery deple-tion. In order to account for potential bias due to underreporting ofnormal battery depletion, a device that has not been returned butwhose explant was attributed to normal battery depletion – by thephysician’s opinion – is therefore added to the normal battery deple-tion statistics. “Estimated normal battery depletion” is shown only fordevice models marketed in the United States.

Worldwide malfunctions Number of devices confirmed out of specification worldwide after im-plant, except because of normal battery depletion.

Years after start of exposure Number of years the device remains in the body after the device isimplanted. The analysis uses the date of sale as a surrogate for dateof implant. The survival analysis calculates time to the nearest day.However, for convenience, the graphs and tables report time in yearsand the analysis stops at 6 years (72 months).

Cumulative survival curves Each survival graph contains the survival curve for freedom frommalfunction, in red. When the device is marketed in the UnitedStates, a second survival curve for normal battery depletion and mal-function is shown on the same graph (the lower curve), in black. Atable provides annual values corresponding to the upper curve, withconfidence limits.

Devices with/without compro-mised therapy

The number of malfunctions with and without compromised therapyis documented in a table below the survival curves data.

Sorin Group CRM 9


Cardiac Resynchronization Therapy (CRT)

3 Cardiac Resynchronization Therapy (CRT)

3.1 Cardiac Resynchronization Therapy Defibrillators (CRT-D)

3.1.1 Paradym CRT 8750 - sonR 8770

PARADYM CRT 8750PARADYM SonR 8770


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 6

532 530 Not available 0Upper confidence interval (+)Lower confidence interval (-)




65%70%75%80%85%90%95%

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Cumulative survival from malfunction

Sorin Group CRM 10


3.1 Cardiac Resynchronization Therapy Defibrillators (CRT-D)

3.1.2 Ovatio CRT 6750

OVATIO CRT 6750



3412 3204 Not available 1 100.00% 99.95% 99.95%

Upper confidence interval (+) 0.04% 0.04%

Lower confidence interval (-) 0.30% 0.30%




65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

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3.1.3 Alto 2 MSP 627 - Alto MSP 617

A Field Safety Notice was issued for a limited number of Alto 2 MSP 627 and Alto MSP 617 devices. Pleaserefer to Section 6.1, pp. 56-67.

Sorin Group CRM 11


3.2 Cardiac Resynchronization Therapy Pacemakers (CRT-P)

3.2 Cardiac Resynchronization Therapy Pacemakers (CRT-P)

3.2.1 Talent 3 MSP 353 - Talent MSP AF 343 - MSP 313

TALENT 3 MSP 353TALENT MSP 313TALENT MSP AF 343



1627 1163 Not available 3 99.81% 99.81% 99.81% 99.81%

Upper confidence interval (+) 0.13% 0.13% 0.13% 0.13%

Lower confidence interval (-) 0.39% 0.39% 0.39% 0.39%




65%70%75%80%85%90%95%

100%

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Cumu

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Sorin Group CRM 12


3.3 Cardiac Resynchronization Therapy Leads


3.3.1 Situs OTW UW28D

SITUS OTW UW28D


EstimatedWorldwide active Worldwideimplants implants malfunctions 1 2 3 4 5 6

3188 2308 0 100.00% 100.00% 100.00% 100.00% 100.00%

Upper confidence interval (+)Lower confidence interval (-)


with 95 % confidence interval, as a function of years after implantCumulative survival from malfunction


65%70%75%80%85%90%95%

100%

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Sorin Group CRM 13



3.3.2 Situs LV UC28D - UL28D

SITUS LV UC28DSITUS LV UL28D



2172 1391 0 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%





65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

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Sorin Group CRM 14


Tachycardia Therapy

4 Tachycardia Therapy

4.1 Implantable Cardioverter Defibrillators (ICDs)

4.1.1 Ovatio DR 6550 - VR 6250

OVATIO DR 6550OVATIO VR 6250


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 613286 13127 5 6 99.98% 99.94% 99.94%

Upper confidence interval (+) 0.02% 0.04% 0.04%

Lower confidence interval (-) 0.05% 0.08% 0.08%




65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

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Sorin Group CRM 15


4.1 Implantable Cardioverter Defibrillators (ICDs)

4.1.2 Alto 2 DR 624 - VR 625

ALTO 2 DR 624ALTO 2 VR 625



2704 2497 67 18 99.74% 99.48% 99.36% 99.31%






65%70%75%80%85%90%95%

100%

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Cumu

lative

survi

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A Field Safety Notice was issued for a limited number of Alto 2 DR 624 and Alto 2 VR 625 devices. Pleaserefer to Section 6.1, pp. 56-67.

4.1.3 Alto DR 614 - VR 615

A Field Safety Notice was issued for a limited number of Alto DR 614 and Alto VR 615 devices. Please referto Section 6.1, pp. 56-67.

Sorin Group CRM 16


4.2 Defibrillation Leads


4.2.1 Isoline 2CR5 - 2CR6 - 2CT6

ISOLINE 2CR5ISOLINE 2CR6ISOLINE 2CT6



6037 5768 8 99.91% 99.78% 99.78%

Upper confidence interval (+) 0.05% 0.12% 0.12%

Lower confidence interval (-) 0.12% 0.26% 0.26%




65%70%75%80%85%90%95%

100%

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Sorin Group CRM 17



4.2.2 Swift 4041

SWIFT 1CT 4041



2434 2142 0 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%





65%70%75%80%85%90%95%

100%

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Sorin Group CRM 18


Bradycardia Therapy

5 Bradycardia Therapy

5.1 Pacemakers

5.1.1 Reply DR - D - VDR - SR

REPLY DREPLY DRREPLY SRREPLY VDR


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 640059 39974 0 1 99.99% 99.99%

Upper confidence interval (+) 0.00% 0.00%

Lower confidence interval (-) 0.03% 0.03%




65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


A Field Safety Notice was issued for a limited number of Reply SR devices. Please refer to Section 6.2,pp. 68-77.

Sorin Group CRM 19


5.1 Pacemakers

5.1.2 Symphony DR 2550 - SOLE DR

SOLE DRSYMPHONY DR 2550


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 6104578 102828 378 36 99.99% 99.97% 99.96% 99.94% 99.93%

Upper confidence interval (+) 0.01% 0.01% 0.01% 0.02% 0.03%

Lower confidence interval (-) 0.01% 0.01% 0.02% 0.02% 0.05%




65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

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survi

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A Field Safety Notice was issued for a limited number of Symphony DR 2550 devices. Please refer to Sec-tion 6.2, pp. 68-77.

Sorin Group CRM 20


5.1 Pacemakers

5.1.3 Symphony D 2450 - VDR 2350 - SOLE VDR

SOLE VDRSYMPHONY D 2450SYMPHONY VDR 2350


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 610137 8169 Not available 7 99.96% 99.93% 99.93% 99.93%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 21


5.1 Pacemakers

5.1.4 Symphony SR 2250 - SOLE SR

SOLE SRSYMPHONY SR 2250


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 628217 23308 22 6 99.99% 99.98% 99.97% 99.97%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 22


5.1 Pacemakers

5.1.5 Rhapsody DR 2510 - SR 2210 - + DR 2530

RHAPSODY DR 2510RHAPSODY SR 2210RHAPSODY+ DR 2530


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 629388 28837 140 14 99.99% 99.96% 99.94% 99.94% 99.90%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


A Field Safety Notice was issued for a limited number of Rhapsody DR 2510, Rhapsody SR 2210 and Rhap-sody + DR 2530 devices. Please refer to Section 6.2, pp. 68-77.

Sorin Group CRM 23


5.1 Pacemakers

5.1.6 Rhapsody D 2410 - S 2130

RHAPSODY D 2410RHAPSODY S 2130


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 613292 10528 Not available 10 99.97% 99.91% 99.90% 99.90% 99.90%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


A Field Safety Notice was issued for a limited number of Rhapsody 2410 devices. Please refer to Section 6.2,pp. 68-77.

Sorin Group CRM 24


5.1 Pacemakers

5.1.7 Talent 3 DR 253 - VDR 263

TALENT 3 DR 253TALENT 3 VDR 263



9934 6707 Not available 7 99.96% 99.96% 99.93% 99.91% 99.91%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 25


5.1 Pacemakers

5.1.8 Talent II DR 233

TALENT II DR 233








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 26


5.1 Pacemakers

5.1.9 Talent II SR 133

TALENT II SR 133



6579 5689 190 2 99.98% 99.97% 99.97% 99.97% 99.97% 99.97%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 27


5.1 Pacemakers

5.1.10 Talent DR 213

TALENT DR 213








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 28


5.1 Pacemakers

5.1.11 Talent AF 243

TALENT AF 243



2557 1550 Not available 3 99.92% 99.92% 99.92% 99.87% 99.87% 99.87%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 29


5.1 Pacemakers

5.1.12 Talent D 210

TALENT D 210



6915 4232 Not available 2 100.00% 99.98% 99.98% 99.98% 99.96% 99.96%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 30


5.1 Pacemakers

5.1.13 Talent SR 113

TALENT SR 113








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 31


5.1 Pacemakers

5.1.14 Brio DR 212 - DR 222

BRIO DR 212BRIO DR 222








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 32


5.1 Pacemakers

5.1.15 Brio D 220

BRIO D 220



9701 5122 2574 7 99.98% 99.98% 99.93% 99.92% 99.92% 99.92%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 33


5.1 Pacemakers

5.1.16 Brio SR 112

BRIO SR 112



6713 4823 101 4 99.97% 99.97% 99.94% 99.94% 99.94% 99.94%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 34


5.1 Pacemakers

5.1.17 Elect DR - D - VDR - SR

ELECT DELECT DRELECT DRMELECT SRELECT SRCELECT VDR


Estimated EstimatedWorldwide active normal batt. Worldwideimplants implants depletion malfunctions 1 2 3 4 5 619715 12107 Not available 64 99.97% 99.95% 99.89% 99.82% 99.61% 99.53%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 35


5.1 Pacemakers

5.1.18 Diapason - Elect XS

DIAPASONDIAPASON CELECT XSELECT XS CELECT XS PLUSELECT XS PLUS C








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 36


5.1 Pacemakers

5.1.19 Neway - NewLiving

NEWAY DNEWAY DRNEWAY SRNEWAY VDRNEWLIVING CHFNEWLIVING DRNEWLIVING SR








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


A Field Safety Notice was issued for a limited number of Neway DR devices. Please refer to Section 6.2,pp. 68-77.

Sorin Group CRM 37


5.1 Pacemakers

5.1.20 Pacemaker Synopsis

The table presented below summarizes device information:

Market Estimated Estimated Devices with Devices withoutrelease Worldwide active normal batt. Worldwide compromised compromised

Models Family date (CE) implants implants depletion malfunctions therapy therapyREPLY D, Reply Dec-06 40059 39974 - 1 1 0REPLY DR, Apr-07REPLY SR, Apr-07REPLY VDR Apr-07SYMPHONY DR 2550, Symphony Mar-02 104578 102828 378 36 15 21SOLE DR -SYMPHONY VDR 2350, Symphony Apr-03 10137 8169 - 7 2 5SYMPHONY D 2450, Apr-03SOLE VDR -SYMPHONY SR 2250, Symphony Oct-02 28217 23308 22 6 3 3SOLE SR -RHAPSODY DR 2510, Rhapsody May-03 29388 28837 140 14 7 7RHAPSODY SR 2210, Jun-03RHAPSODY+ DR 2530 May-03RHAPSODY D 2410, Rhapsody May-03 13292 10528 - 10 9 1RHAPSODY S 2130 Jun-03TALENT 3 DR 253, Talent Jul-02 9934 6707 - 7 4 3TALENT 3 VDR 263 Dec-02TALENT II DR 233 Talent Jul-00 12169 9087 2291 6 1 5TALENT II SR 133 Talent Sep-01 6579 5689 190 2 1 1TALENT DR 213 Talent Nov-97 39328 26558 8936 55 38 17TALENT AF 243 Talent Mar-01 2557 1550 - 3 1 2TALENT D 210 Talent Jun-98 6915 4232 - 2 2 0TALENT SR 113 Talent Nov-98 10229 7902 374 3 3 0BRIO DR 212, Brio May-98 19924 12936 3133 8 6 2BRIO DR 222 -BRIO D 220 Brio Feb-99 9701 5122 2574 7 3 4BRIO SR 112 Brio Nov-98 6713 4823 101 4 2 2ELECT D, Elect Jan-01 19715 12107 - 64 38 22ELECT DR, Apr-01ELECT DRM, Apr-01ELECT SR, Apr-01ELECT SRC, Apr-01ELECT VDR Apr-01DIAPASON, Elect XS Apr-00 55362 38203 - 4 1 3DIAPASON C, Apr-00ELECT XS, Apr-00ELECT XS C, Apr-00ELECT XS PLUS, Apr-00ELECT XS PLUS C Apr-00NEWAY D, Neway Feb-03 47418 35451 - 17 6 11NEWAY DR, Dec-02NEWAY SR, Feb-03NEWAY VDR, Feb-03NEWLIVING CHF, Mar-05NEWLIVING DR, Dec-04NEWLIVING SR Aug-05

Sorin Group CRM 38


5.1 Pacemakers

The table presented below summarizes cumulative survival probability from malfunction:

Models Family 1 2 3 4 5 6REPLY D, Reply 99.99% 99.99%REPLY DR,REPLY SR,REPLY VDRSYMPHONY DR 2550, Symphony 99.99% 99.97% 99.96% 99.94% 99.93%SOLE DRSYMPHONY VDR 2350, Symphony 99.96% 99.93% 99.93% 99.93%SYMPHONY D 2450,SOLE VDRSYMPHONY SR 2250, Symphony 99.99% 99.98% 99.97% 99.97%SOLE SRRHAPSODY DR 2510, Rhapsody 99.99% 99.96% 99.94% 99.94% 99.90%RHAPSODY SR 2210,RHAPSODY+ DR 2530RHAPSODY D 2410, Rhapsody 99.97% 99.91% 99.90% 99.90% 99.90%RHAPSODY S 2130TALENT 3 DR 253, Talent 99.96% 99.96% 99.93% 99.91% 99.91%TALENT 3 VDR 263TALENT II DR 233 Talent 99.98% 99.97% 99.97% 99.97% 99.96% 99.95%TALENT II SR 133 Talent 99.98% 99.97% 99.97% 99.97% 99.97% 99.97%TALENT DR 213 Talent 99.96% 99.93% 99.91% 99.89% 99.87% 99.85%TALENT AF 243 Talent 99.92% 99.92% 99.92% 99.87% 99.87% 99.87%TALENT D 210 Talent 100.00% 99.98% 99.98% 99.98% 99.96% 99.96%TALENT SR 113 Talent 100.00% 99.99% 99.97% 99.97% 99.97% 99.97%BRIO DR 212, Brio 99.99% 99.98% 99.97% 99.97% 99.96% 99.95%BRIO DR 222BRIO D 220 Brio 99.98% 99.98% 99.93% 99.92% 99.92% 99.92%BRIO SR 112 Brio 99.97% 99.97% 99.94% 99.94% 99.94% 99.94%ELECT D, Elect 99.97% 99.95% 99.89% 99.82% 99.61% 99.53%ELECT DR,ELECT DRM,ELECT SR,ELECT SRC,ELECT VDRDIAPASON, Elect XS 100.00% 100.00% 99.99% 99.99% 99.99% 99.99%DIAPASON C,ELECT XS,ELECT XS C,ELECT XS PLUS,ELECT XS PLUS CNEWAY D, Neway 99.99% 99.99% 99.98% 99.93% 99.92% 99.92%NEWAY DR,NEWAY SR,NEWAY VDR,NEWLIVING CHF,NEWLIVING DR,NEWLIVING SR

Cumulative survival from malfunction (excluding normal battery depletion)with 95 % confidence interval, as a function of years after implant

Sorin Group CRM 39


5.2 Pacing Leads

5.2 Pacing Leads

5.2.1 XFINE TX25D - TX26D

Xfine TX25DXfine TX26D



3777 3606 3Upper confidence interval (+)Lower confidence interval (-)




65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 40


5.2 Pacing Leads

5.2.2 Stelix II BRF24D - BRF25D - BRF26D

STELIX II BRF24DSTELIX II BRF25DSTELIX II BRF26D



6444 5034 1 99.98% 99.98% 99.98% 99.98%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 41


5.2 Pacing Leads

5.2.3 Stelid II BJF24D - BJF25D

STELID II BJF24DSTELID II BJF25D


EstimatedWorldwide active Worldwideimplants implants malfunctions 1 2 3 4 5 627186 20704 1 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 42


5.2 Pacing Leads

5.2.4 Stelid II BTF25D - BTF26D

STELID II BTF25DSTELID II BTF26D








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 43


5.2 Pacing Leads

5.2.5 Stelid II UTF26D

STELID II UTF26D



5733 3614 0 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%





65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 44


5.2 Pacing Leads

5.2.6 Stelix BR45D - BR46D

STELIX BR45DSTELIX BR46D







65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 45


5.2 Pacing Leads

5.2.7 Stelid BT45D - BT46D

STELID BT45DSTELID BT46D








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 46


5.2 Pacing Leads

5.2.8 Stelid BS45D - BS46D

STELID BS45DSTELID BS46D








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


A Field Safety Notice was issued for a limited number of Stelid BS45D leads. Please refer to Section 6.3,p. 78.

Sorin Group CRM 47


5.2 Pacing Leads

5.2.9 BEST mini

MiniBEST



3084 1916 0 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%





65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 48


5.2 Pacing Leads

5.2.10 S200 AB

S 200 AB








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 49


5.2 Pacing Leads

5.2.11 S 80 JB

S 80 JB








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 50


5.2 Pacing Leads

5.2.12 HEPTA 4B

HEPTA 4B



9378 6017 16 99.93% 99.87% 99.81% 99.79% 99.79% 99.79%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 51


5.2 Pacing Leads

5.2.13 S 80 TB

S 80 TB








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 52


5.2 Pacing Leads

5.2.14 S 80 UTS

S 80 UTS








65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 53


5.2 Pacing Leads

5.2.15 Pacing Lead Synopsis

The table presented below summarizes leads information:

Market Estimated Devices with Devices withoutrelease Worldwide active Worldwide compromised compromised Electrical

Models Family date (CE) implants implants malfunctions therapy therapy MalfunctionsSTELIX II BRF24D, Stelix Dec-01 6444 5034 1 1 0 0STELIX II BRF25D, Dec-01STELIX II BRF26D Dec-01STELID II BJF24D, Stelid Feb-01 27186 20704 1 0 1 1STELID II BJF25D Feb-01STELID II BTF25D, Stelid Sep-99 75865 54943 2 2 0 2STELID II BTF26D Sep-99STELID II UTF26D Stelid Jun-00 5733 3614 0 0 0 0STELIX BR45D, Stelix Mar-99 10207 6610 0 0 0 0STELIX BR46D Mar-99STELID BT45D, Stelid Jul-97 33833 20098 2 2 0 2STELID BT46D Jul-97STELID BS45D, Stelid May-97 19189 12812 1 1 0 1STELID BS46D May-97Xfine TX25D, Xfine Apr-08 3777 3606 3 3 0 3Xfine TX26DMiniBEST Best Jul-00 3084 1916 0 0 0 0S 200 AB S 200 Dec-94 14717 8561 3 2 1 3S 80 JB S 80 Dec-94 23208 13591 1 1 0 1HEPTA 4B Hepta May-00 9378 6017 16 16 0 15S 80 TB S 80 Dec-94 92688 54438 8 7 1 7S 80 UTS S 80 Dec-94 14714 8832 1 1 0 1

Sorin Group CRM 54


5.2 Pacing Leads

The table presented below summarizes cumulative survival probability from malfunction:

Models Family 1 2 3 4 5 6STELIX II BRF24D, Stelix 99.98% 99.98% 99.98% 99.98%STELIX II BRF25D,STELIX II BRF26DSTELID II BJF24D, Stelid 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%STELID II BJF25DSTELID II BTF25D, Stelid 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%STELID II BTF26DSTELID II UTF26D Stelid 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%STELIX BR45D, Stelix 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%STELIX BR46DSTELID BT45D, Stelid 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%STELID BT46DSTELID BS45D, Stelid 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%STELID BS46DXfine TX25D, XfineXfine TX26DMiniBEST Best 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%S 200 AB S 200 100.00% 99.98% 99.98% 99.98% 99.98% 99.98%S 80 JB S 80 100.00% 100.00% 99.99% 99.99% 99.99% 99.99%HEPTA 4B Hepta 99.93% 99.87% 99.81% 99.79% 99.79% 99.79%S 80 TB S 80 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%S 80 UTS S 80 99.99% 99.99% 99.99% 99.99% 99.99% 99.99%

Cumulative survival from malfunctionwith 95 % confidence interval, as a function of years after implant

Sorin Group CRM 55


Field Safety Notices

6 Field Safety Notices

6.1 Cardioverter defibrillators

6.1.1 Alto and Alto 2, Group 1

Original date of Field safety notice: February 2004

Field Safety Notice descriptionA Field Safety Notice was issued for this group of devices that were manufactured before April 17, 2003(Group 1). The notification states that premature battery depletion and/or prolonged charge time can occurdue to metal migration, in a limited number of Alto and Alto 2 implantable cardioverter defibrillators (modelsDR 614, VR 615, MSP 617, DR 624, and VR 625). Premature battery depletion and/or prolonged chargetime can result in unavailability of pacing, cardioversion, and defibrillation therapy. This condition can occurbetween two follow-up visits. No permanent adverse effect on a patient’s health has been reported.

Patient recommendationsThe notification recommends strictly observing a follow-up interval of three (3) months for these devices, inconformance with recommendations provided in the user’s manual. Depending on the circumstances, thosepatients known to have frequent recent episodes of ventricular fibrillation might be at greater risk if the devicedoes not perform as expected between follow-up visits. Those patients could require prophylactic explantationor more frequent visits. Other patients, including pacemaker-dependent patients, could also benefit fromprophylactic explantation or more frequent visits.

Sorin Group CRM 56



Alto MSP 617 Group 1

Alto MSP 617 - GR 1

Cutoff date: 30-Jun-2009Analysis stops at 72 months


50 39 Not available 1 100.00% 97.90% 97.90% 97.90% 97.90% 97.90%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 57



Alto 2 DR 624 - Alto DR 614 Group 1

Alto DR 614 - GR 1ALTO 2 DR 624 - GR 1



1448 1020 151 164 96.86% 92.90% 89.87% 88.45% 88.29% 88.29%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 58



Alto 2 VR 625 - Alto VR 615 Group 1

Alto VR 615 - GR 1ALTO 2 VR 625 - GR 1



273 196 16 44 96.31% 88.46% 85.05% 83.45% 83.45% 83.45%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 59




Original date of Field Safety Notice: July 2005

Field Safety Notice descriptionThe Field Safety Notice described above for Group 1 was extended to this second group of devices manufac-tured from April 17, 2003 through July 31, 2003 (Group 2). No permanent adverse effect on a patient’s healthhas been reported in this group.

Patient recommendationsThe Field Safety Notice recommends strictly observing a follow-up interval of three (3) months for these de-vices, in conformance with recommendations provided in the user’s manual. Depending on the circumstances,those patients known to have frequent recent episodes of ventricular fibrillation might be at greater risk if thedevice does not perform as expected between follow-up visits. Those patients could require prophylactic ex-plantation or more frequent visits. Other patients, including pacemaker-dependent patients, could also benefitfrom prophylactic explantation or more frequent visits.

Sorin Group CRM 60



Alto MSP 617 Group 2

Alto MSP 617 - GR 2



48 37 Not available 2 97.87% 95.69% 95.69% 95.69% 95.69% 95.69%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 61







315 224 33 34 99.04% 94.82% 91.51% 89.47% 88.75% 88.75%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 62







34 27 2 3 97.04% 97.04% 90.94% 90.94% 90.94%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 63





Field Safety Notice descriptionThe Field Safety Notice described above for Group 1 was extended to this third group of devices, manufacturedfrom August 2003 through August 2004 (Group 3). No permanent adverse effect on a patient’s health hasbeen reported in this group. Although a Field Safety Notice was issued for this group, performance comparesfavorably with recently-published data indicate that the average malfunction rate for all ICDs is approximately1% per year3.

Patient recommendationsIn Group 3, the Field Safety Notice recommends strictly observing a follow-up interval of three (3) months forthese devices, in conformance with recommendations provided in the user’s manual.

3Maisel WH. Pacemaker and ICD Generator Malfunctions. Policy Conference on Pacemaker and ICD Performance presented by theHeart Rhythm Society and the Food and Drug Administration. September 16, 2005.

Sorin Group CRM 64



Alto 2 MSP 627 - Alto MSP 617 Group 3

Alto MSP 617 - GR 3ALTO 2 MSP 627 - GR 3



190 156 Not available 2 99.46% 99.46% 99.46% 98.87% 98.87%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 65







1179 951 120 22 99.40% 98.80% 98.44% 98.17% 98.07%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 66







453 393 28 4 99.55% 99.33% 99.33% 99.33% 99.09%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 67


6.2 Pacemakers

6.2 Pacemakers

6.2.1 Symphony and Rhapsody, Group 1

Original date of Field Safety Notice: October 2005

Field Safety Notice descriptionA Field Safety Notice was issued for this group of devices. A no-output condition was observed in a limitednumber of Symphony or Rhapsody pacemakers (models Symphony DR 2550, Symphony SR 2250, RhapsodyDR+ 2530, Rhapsody DR 2510, Rhapsody D 2410, Rhapsody SR 2210), due to metal migration caused by amanufacturing process performed systematically in this population, identified as Group 1. No injury or deathhas been reported in this group.

Patient recommendationsThe notification states that no measurable change in device characteristics was identified that could warn ofan impending incident. Consequently, the Field Safety Notice does not recommend more frequent monitoring.Depending on the circumstances, pacemaker-dependent patients implanted with units manufactured in thisgroup could require prophylactic replacement.

Sorin Group CRM 68


6.2 Pacemakers

Symphony DR 2550 Group 1

SYMPHONY DR 2550 - GR 1



693 630 12 33 99.28% 98.26% 96.36% 95.62% 95.17%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 69


6.2 Pacemakers

Rhapsody DR 2510 - SR 2210 - + DR 2530 Group 1

RHAPSODY DR 2510 - GR 1RHAPSODY SR 2210 - GR 1RHAPSODY+ DR 2530 - GR 1



653 612 9 14 99.85% 99.38% 98.45% 98.14% 97.98%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 70


6.2 Pacemakers

Rhapsody D2410 Group 1

RHAPSODY D 2410 - GR 1



118 73 Not available 1 99.15% 99.15% 99.15% 99.15% 99.15%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 71


6.2 Pacemakers

6.2.2 Symphony and Rhapsody, Group 2

Original date of Field Safety Notice: October 2005

Field Safety Notice descriptionA manufacturing process that caused malfunctions described in Group 1 above was also performed for somedevices in this second population identified as Group 2, although no similar malfunctions have been reported.Consequently, the Field Safety Notice described above also included Group 2.

Patient recommendationsNo measurable change in device characteristics was identified that could warn of an impending incident.Consequently, the Field Safety Notice does not recommend more frequent monitoring. For Group 2, becauserecently-published data indicate that the average malfunction rate for all pacemakers is approximately 0.15%per year4, and because of the small but non-zero risk associated with device replacement, the Field SafetyNotice does not recommend prophylactic replacement.

4Maisel WH. Pacemaker and ICD Generator Malfunctions. Policy Conference on Pacemaker and ICD Performance presented by theHeart Rhythm Society and the Food and Drug Administration. September 16, 2005.

Sorin Group CRM 72


6.2 Pacemakers

Symphony DR 2550 Group 2

SYMPHONY DR 2550 - GR 2



472 448 8 2 100.00% 99.57% 99.57% 99.57% 99.57% 99.57%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 73


6.2 Pacemakers

Rhapsody DR 2510 - SR 2210 Group 2

RHAPSODY DR 2510 - GR 2RHAPSODY SR 2210 - GR 2



301 284 4 2 100.00% 100.00% 99.66% 99.66% 99.32% 99.32%






65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 74


6.2 Pacemakers

Rhapsody D2410 Group 2

RHAPSODY D 2410 - GR 2



130 80 Not available 0 100.00% 100.00% 100.00% 100.00% 100.00% 100.00%





65%70%75%80%85%90%95%

100%

0 1 2 3 4 5 6


Cumu

lative

survi

val

.


Sorin Group CRM 75


6.2 Pacemakers

6.2.3 Symphony and Rhapsody: 7 units

Original date of Field Safety Notice: November 2008

Field Safety Notice descriptionA Field Safety Notice was issued in relation to a limited series of 7 units of Symphony / Rhapsody cardiacpacemakers, for which the absence of a metallic spring was confirmed through retrospective inspection of themanufacturing records. This metallic spring is used to help ensure the contact between a proximal terminalof the pacemaker and a proximal ring of an IS-1 pacing lead, i.e. to ensure proper operation in BIPOLARconfiguration; device operation in UNIPOLAR configuration was not affected by this Notice. No injury or deathhas occurred as a result of the absence of this component.

Patient recommendationsBecause the absence of this component affected device operation in bipolar configuration only, it was recom-mended to re-program the pacing and sensing polarities to UNIPOLAR in the concerned chamber. Dependingon the circumstances (patient’s conditions, identified chamber with a missing spring, polarity of the implantedlead and programmed settings during the last follow-up visit), a prompt follow-up visit was recommended tore-program the polarities to Unipolar. It was also recommended to mark patient records – including the patientidentification card – to indicate that these polarities must remain Unipolar.

6.2.4 Neway DR: 45 units


Field Safety Notice descriptionA Field Safety Notice was issued in relation to a limited series of 45 cardiac pacemakers, Neway DR model,distributed in Europe. The notification states that these devices contained a version of a microcontrollerintegrated circuit that did not allow automatic storing of the data coming from the intracardiac EGM (IEGM)into the device memory. To overcome this limitation, storing of data was performed by a dedicated softwareroutine. This software routine caused additional current drain that reduced longevity in devices with IEGMactivated, compared to the devices with the IEGM deactivated. Available programmer software did not takeinto account the additional current required for the IEGM function when estimating the remaining longevity.

Patient recommendationsRevised programmer software (SmartView 2.06 for Orchestra programmer – version 3.6.04 for PMP 2000programmer or higher versions) was distributed to calculate the remaining longevity accurately with or withoutIEGM enabled. For all of the devices included in this field safety notice, a prompt follow-up visit and deviceinterrogation was recommended utilizing this revised programmer software.

Sorin Group CRM 76


6.2 Pacemakers

6.2.5 Programmer software version associated with Reply SR

Original date of Field Safety Notice: September 2007

Field Safety Notice descriptionA Field Safety Notice was issued for an anomaly in programmer software, Smartview version 2.06 or earlier,when reprogramming Reply SR single chamber cardiac pacemakers (distributed in Europe). The notificationstated that when the chamber was set to “V” (pacemaker connected to a lead implanted in the ventricle),reprogramming of the pulse amplitude and pulse width was not effective, and they remained equal to theas-shipped values (3.5 V amplitude, 0.35 ms pulse width). When the chamber was set to “A” (pacemakerconnected to a lead implanted in the atrium), each programmable parameter – including pulse amplitude andpulse width – could be reprogrammed as expected. This software anomaly affected Reply SR single chamberpacemakers only; other pacemaker models were not affected.

Patient recommendationsRevised programmer software, SmartView version 2.08 for Orchestra programmer was distributed to correctthis unexpected behavior. For some of the devices included in this field safety notice (Reply SR single chambermodels set to “V” chamber), and based upon the evaluation of specific criteria (e.g. pacemaker reprogrammedafter implant or not, pacemaker dependency, pacing threshold results at implant), a prompt follow-up visit anddevice interrogation were recommended utilizing this revised programmer software to check the programmedsettings and correct the pulse amplitude and pulse width, if needed.

Sorin Group CRM 77


6.3 Leads

6.3 Leads

6.3.1 Stelid BS45D: 54 units

Original date of Field Safety Notice: December 2006

Field Safety Notice descriptionA Field Safety Notice was issued for a limited number of Stelid BS45D leads (54 units). A loss of pacingand sensing condition was observed on one BS45D lead, due to an incorrect crimping operation for the fixedscrew during the manufacturing of an isolated lot of BS45D. No deterioration in patient’s health was reportedas a result of the defect.

Patient recommendationsELA recommends performing a follow-up visit every six months over the first two years after implantation. Thelead electrical performance and stability should be checked during each follow-up: pacing/sensing thresholdand pacing impedance.

Sorin Group CRM 78


Contacts

7 Contacts

List of QA local representatives

Sorin Group BelgiumJ. BakersExcelsiorlaan 331930 ZaventemBELGIUMTel. +32-2 247 78 90Fax: +32-2 245 17 92

Sorin Group Canada Inc.R. Gordon280 Hillmount Road Unit 8Markham, Ontario L6C3A1CANADATel. +1-416 751 8787Fax: +1-416 751 9849

Sorin Group FranceJ. CourvilleParc d’affaires Noveos4, avenue Réaumur92140 ClamartFRANCETel. +33-1 46 01 89 94Fax: +33-1 46 01 89 60

Sorin Group Deutschland GmbHL. PriceliusLindberghstrasse 25D-80939 MünchenGERMANYTel. +49-89 32 301 353Fax: +49-89 32301 404

Sorin Group ItaliaA. Pincirolivia Benigno Crespi 1720159 MilanITALYTel. +39-02 6946 5211Fax: +39-02 6946 5311

Sorin Biomedica Japan K.K.K. NumataNBF Akasaka Sanno Square Bld8F2-2-12, Akasaka, Minato-kuTokyo 107-0052JAPANTel. +81-3 3560 8250Fax: +81-3 3560 2020

Sorin Group Nederland N.V.N. YaketePaasheuvelweg 1P.O. Box 120601100 AB AmsterdamNETHERLANDSTel. +31-20311 32 11Fax: +31-20311 32 19

Sorincardio LdaM. BottazziRua do Proletariado, 1Quinta do Paizinho2790-138 CarnaxidePORTUGALTel. +351-21 425 5218Fax: +351-21 425 5206

Sorin Group ScandinaviaP. HaleniusMedevivägen 78591 33 MotalaSWEDENTel. +46-708 52 99 61Fax: +46-406 99 27 71

Sorin Group Espana S.L.M.J. IglesiasEdificio Trade Center IIAv. de les Crts Catalanes, 8, 3◦

08173 Sant Cugat del VallèsBarcelonaSPAINTel. +34-93 544 22 44Fax: +34-93 675 22 52

Sorin Group International AGP. HeizmannSeefeldstrasse 69CH-8008 ZürichSWITZERLANDTel. +41-43 488 36 20Fax: +41-43 488 35 37

ELA Medical Inc.C. Doty2950 Xenium Lane NorthPlymouth, 55441 (MN)USATel. +1 763/519-9411Fax: +1 877/443-3134

Sorin Group UK Ltd.C. Breen1370 Montpellier CourtGloucester Business ParkGloucester GL3 4AHUKTel. +44 (0)1452 638500Fax: +44 (0)1452 638530

Sorin Group CRM 79


Contacts

Editorial Board and Staff

EditorBenoît CLINCHAMPS, VP Quality Assurance and Regulatory Affairs of CRM Business Unit

Independent Product Performance Review BoardPhilip R. ERSHLER, Ph.D. Bioengineering, Salt Lake City, United StatesRoger A. FREEDMAN, M.D., Chairman of the Board, Salt Lake City, Utah, United StatesPhilippe MABO, M.D., Rennes, FranceHoward MANN, M.D., Salt Lake City, Utah, United StatesGreg STODDARD, MPH, Salt Lake City, Utah, United States

Sorin CRM Review BoardStefano DI LULLO, President of CRM Business UnitBenoît CLINCHAMPS, VP Quality Assurance and Regulatory Affairs of CRM Business Unit

AuthorsChantal CADIOUFabien OBERRIETTERDavid THIERMAN

Sorin Group Trademarks

The following trademarks belong to Sorin Group:

Alto R©

BestTM

Brio R©

DiapasonTM

ElectTM

HeptaTM

IsolineTM

NewayTM

NewLivingTM

OvatioTM

Paradym R©

Reply R©

RhapsodyTM

Situs R©

Stelid R©

Stelix R©

SwiftTM

Symphony R©

S80TM

S200TM

Talent R©

XfineTM

Sorin Group CRM 80

CARDIAC RHYTHM MANAGEMENT Quality Assurance & Regulatory Affairs - Parc d’affaires Noveos - 4, avenue Réaumur - 92140 Clamart - France

Phone: +33 (0)1 46 01 33 33 - Fax: +33 (0)1 46 01 36 37 - www.sorin-crm.com

©2009 Sorin SpA - All Rights Reserved - November 2009 - ref: RE06600006- UK

November 2009

CARDIAC RHYTHM MANAGEMENT

PRODUCT PERFORMANCE REPORT

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