CRM Product Performance Report Q4  2011

Product Advisory

01-Dec-09 — Subpectoral Implant 2009

COGNIS

Models N106/N107/N108/N118/N119/P106/P107/P108

TELIGEN VR

Models E102/F102

TELIGEN DR

Models E110/F110/E111/F111

ORIGINAL COMMUNICATION 01-Dec-09 — Subpectoral Implant 2009

Voluntary Physician Advisory

FDA Classification: Class II

This advisory is limited to devices identified in the product model list that were implanted subpectorally. Devices implanted subcutaneously are not included in this advisory.

Boston Scientific has determined that the bond between the header and case could be weakened by significant forces associated with a subpectoral implant procedure or when a device in a subpectoral position is pushed against a rib during contraction of the pectoralis muscle. A weakened header bond may alter lead impedance and introduce noise that may inhibit pacing therapy or initiate inappropriate tachy therapy. Additional mechanical stress applied to a weakened bond may eventually cause header connection wires to fracture, resulting in loss of therapy.

A weakened header bond can result in one or more of the following device behaviors:

• Significant changes in measured lead impedance
• Noise on real-time or stored electrograms
• Intermittent inhibition of pacing
• Inappropriate anti-tachy pacing or shock therapy
• Loss of pacing therapy
• Loss of anti-tachy pacing and shock therapy

No patient deaths related to this behavior have been reported. Patients have required early device replacement due to inappropriate shocks and/or noise induced by pocket manipulation or arm movement.

Rate of Occurrence

The implant orientation of devices is not reported to Boston Scientific, making it difficult to provide rate of occurrence and prediction information. Two (2) reports have been received worldwide of subpectoral implants with weakened header bonds. An estimated 5% of approximately 77,000 COGNIS and TELIGEN devices worldwide have been implanted in a subpectoral location.

The following factors may also impact the risk of failure if implanted in a subpectoral location:

• Exact location of the patient’s ribs relative to the device
• Body size and/or muscle mass of the patient (risk may increase for larger/muscular patients)
• Activity level and/or occupation of the patient (risk may increase for more active patients)

Current Status 07-Oct-11

COGNIS and TELIGEN devices are now available with improved header bond strength in the U.S. and the EU.The stronger bond allows physicians to position the devices in a subpectoral position, if desired.

Reported events (worldwide)

Forty-one (41) reports have been received worldwide of subpectoral implants with weakened header bonds. An estimated 10% of approximately 104,000 COGNIS and TELIGEN devices worldwide have been implanted in a subpectoral location.

There have been no reported patient deaths associated with this advisory.

Rate of Occurrence

The implant orientation of devices is not reported to Boston Scientific. For this reason, no rate of occurrence or rate projection is provided.

Current Recommendation 07-Oct-11

If a patient’s device was implanted subcutaneously, it is excluded from this advisory and no change to current patient management is recommended.

For affected devices implanted in a subpectoral location:

• Follow patient at least once every three months as recommended in device instructions for use.
• Consider advising patients to contact their physician or clinic if they receive shocks, in order to ensure timely review of associated electrograms and other device data via in-clinic or remote interrogation.
• Where available, consider using the LATITUDE® Patient Management System to facilitate remote device checks between in-clinic follow-ups.

COGNIS and TELIGEN devices are now available with improved header bond strength in the U.S. and the EU.The stronger bond allows physicians to position the devices in a subpectoral position, if desired.

Standard Warranty program available, please contact your local representative for terms and conditions.