Urgent Medical Device Information - Subset of Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators - For Health Professionals

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April 16, 2007

Subject: Update to Recommendations Section of April 5, 2007 Product Advisory Letter - Potential for reduced ERI to EOL time due to low-voltage capacitor degradation in a subset of ICDs and CRT-Ds

Dear Health Care Professional,

This letter provides important patient management information regarding a subset of Guidant CRM ICDs and CRT-Ds. Our records indicate that you have implanted or are monitoring patients with one of these devices.

Description of Issue

Boston Scientific has recently identified low-voltage capacitors from a former supplier that may be subject to degradation at a low rate of occurrence. These capacitors may cause accelerated battery depletion and may reduce the time between elective replacement indicator (ERI) and end of life (EOL) to less than three months. Device replacement indicators continue to function normally. Devices in this subset have been removed from distribution. There have been no patient deaths or serious injuries associated with this behavior. There are potentially 710 affected patients in Canada.

Rate of Occurrence

There have been no confirmed reports of shortened ERI to EOL time. However, 19 of approximately 73,000 devices in this population worldwide have been confirmed to have accelerated battery depletion, which could have resulted in shortened ERI to EOL time. While it is projected that less than 2% of this device population may exhibit a shortened ERI to EOL time, follow-up recommendations provided below will eliminate patient risk.

Recommendations

If a patient has a device with a degraded capacitor, the time from implant to 2.65 volts (Middle of Life 2 / MOL2) will be reduced. To determine whether a patient may be at risk for a reduced ERI to EOL time, it is important to note when 2.65 volts (MOL2) was observed. For each patient:

1. Review patient records to assess battery voltage.
2. If battery voltage is above 2.65 volts (MOL2), continue to follow this patient population every three months until the 27 or 32-month implant interval is reached.
3. If battery voltage is at or below 2.65 volts (MOL2), determine the time between device implant and this observation.
4. If the time from implant to 2.65 volts (MOL2) is greater than 27 months (Note: For VITALITY^® EL / 2 EL / HE devices, this value is 32 months), the patient is not at risk for a shortened ERI to EOL time, and this advisory no longer applies.
5. If the time from implant to 2.65 volts (MOL2) is 27 months or less (Note: for VITALITY EL / 2 EL / HE devices, this value is 32 months), the patient should be followed monthly until ERI. For devices that require monthly follow-up, replace the device within 30 days after ERI is displayed as ERI to EOL time may be shortened.

Devices Affected

The potential for shortened ERI to EOL time due to low-voltage capacitor degradation is confined to a subset of devices within the CONTAK RENEWAL^® 3 & 4, VITALITY and VITALITY 2 families. Enclosed is a list of patients at your clinic who were implanted with a device from this population. In addition, a model/serial search tool is available to determine if a specific device is subject to this product advisory (go to the Product Performance Resource Center located at www.guidant.com/ppr/).

Warranty Program

The original warranty program specific to each model will remain in effect.

Further Information

Boston Scientific recognizes the impact of this communication on you and your patients and wants to reassure you that patient safety remains our primary concern. If you have any questions regarding this communication, please contact your local Boston Scientific CRM representative or United States Technical Services at 1.800.CARDIAC (227.3422).

Sincerely,

original signed by

Scott Kadwell
Business Unit Manager
Boston Scientific CRM

PHYSICIAN DEVICE ADVISORY NOTICE

Advisory Date: April 5, 2007

Manufacturer(s): Boston Scientific Corporation

Product(s)

Trade Name	Model Number
VITALITY® DS DR/VR	T125/T135
VITALITY EL	T127
VITALITY AVT	A155
VITALITY 2 DR/VR	T165/T175
VITALITY 2 EL DR/VR	T167/T177
VITALITY DR HE	T180
CONTAK RENEWAL® 3/HE	H170/H175/H177/H179
CONTAK RENEWAL 4/HE	H190/H195/H197/H199
CONTAK RENEWAL 3 RF/HE	H210/H215/H217/H219
CONTAK RENEWAL 4 RF/HE	H230/H235/H239
CONTAK RENEWAL 4 AVT/HE	M170/M175/M177/M179

Manufactured on or before (Date): October 2006

Performance Failure: Potential for reduced ERI to EOL time.

Root Cause (if known): Low-voltage capacitor degradation

Has all affected product been retrieved?: Yes

FDA CLASSIFICATION STATUS

Advisory classification: Clinical Acuity

Class: Decision Pending

1. Total number of units currently implanted
   • USA - 50,850
   • Worldwide - 67,542
2. Estimated number of potentially affected devices of this mode worldwide
   • USA - 55,637
   • Worldwide - 72,467
3. Estimated incidences of this performance failure over the projected life of the device
   • USA - 1.7% (zero incidences of compromised therapy if monitored per guidelines below)
   • Worldwide - 1.7% (zero incidences of compromised therapy if monitored per guidelines below)
4. Total number with observed performance failure
   • USA - 0 - reduced ERI to EOL time (15 - accelerated battery depletion)
   • Worldwide - 0 - reduced ERI to EOL time (19 - accelerated battery depletion)
   • % of performance failures d/b x 100 =
     • USA - 0%
     • Worldwide - 0%
5. Mean age of product in implanted population
   • USA - 15 months
   • Worldwide - 15 months
6. Patient deaths reported
   • No
   • Number of deaths = 0 related to this issue
7. Patient deaths with probable relationship to device failure
   • No
   • Number of deaths = 0

* The data analysis provided in this report was generated by the manufacturer and may be subject to change

DEVICE COMPONENTS AT RISK OF PERFORMANCE FAILURE

• Low-voltage capacitor degradation leading to a decline in battery voltage and reduced time from ERI to EOL

PATIENT MANAGEMENT RECOMMENDATIONS

• Verify normal device function (at normal follow-up interval): Yes
• Verify normal device function (as soon as possible): No

If a patient has a device with a degraded capacitor, the time from implant to 2.65 volts (Middle of Life 2 / MOL2) will be reduced. To determine whether a patient may be at risk for a reduced ERI to EOL time, it is important to note when 2.65 volts (MOL2) was observed. For each patient:

• Review patient records to assess battery voltage.
• If battery voltage is above 2.65 volts (MOL2), continue to follow patient every three months per device labeling.
• If battery voltage is at or below 2.65 volts (MOL2), determine the time between device implant and this observation.
• If the time from implant to 2.65 volts (MOL2) is greater than 27 months (Note: For VITALITY^® EL / 2 EL / HE devices, this value is 32 months), the patient is not at risk for a shortened ERI to EOL time, and this advisory no longer applies.
• If the time from implant to 2.65 volts (MOL2) is 27 months or less (Note: for VITALITY EL / 2 EL / HE devices, this value is 32 months), the patient should be followed monthly until ERI. For devices that require monthly follow-up, replace the device within 30 days after ERI is displayed as ERI to EOL time may be shortened.

Programming changes:

If programming changes are required, specify changes: none required

Accelerated device follow-up: Yes (In some cases). If the time from implant to 2.65 volts (MOL2) is 27 months or less (32 months for VITALITY EL / 2 EL / HE devices), the patient should be followed monthly until ERI.

Timeline - months:

CONTACT

Boston Scientific Cardiac Rhythm Management
4100 Hamline Avenue North
St. Paul, MN 55112-5798
Tel: 651.582.4000
Fax: 651.582.4166
crmevent@guidant.com
www.guidant.com

Boston Scientific Cardiac Rhythm Management
4-505 Apple Creek Boulevard
Markham, Ontario
L3R 5B1
Canada
Tel: 905.947.5800
Fax: 905.947.5830
www.guidantcanada.com