This advisory is limited to devices identified in the COGNIS and TELIGEN 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.
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.
Select this link for additional information regarding 01-Dec-09, Subpectoral Implant 2009 or contact your local Boston Scientific CRM representative, United States Technical Services at 1.800.CARDIAC (227.3422) or European Technical Services at +32 2 416 7222.
A Closer Look articles provide educational/training information on a variety of topics to better understand the function of Boston Scientific CRM products. Articles are now available at bostonscientific.com and bostonscientific-international.com (A4 format and translations, where available).
Published December 18, 2009
