Recall Z-0610-2010 · LWP Implantable Pulse Generator, Pacemaker (Non-Crt)

Boston Scientific CRM Corp

Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

Date	Jan 13, 2010 (initiated Dec 1, 2009)
Status	Terminated
Reason	BSC CRM provided important patient management information regarding Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs. Engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. A weakened header bond may alter lead impedance and introduce noise
Root cause	Device Design
Action	Boston Scientific CRM issued an "Urgent Medical Device Correction" letter dated December 01, 2009. The letter described the issue and potential device behavior. The letter provided recommendations to avoid issues relating to the affected device until improved devices become available. For further information, contact your local Boston Scientific CRM representative, United States Technical Services at 1-800-227-3422, or European Technical Services at +32-2-416-7222.
Quantity	60,211
Distribution	Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Repu
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.