Boston Scientific warns on battery issues in certain implantable defibrillators

September 19, 2013 by Arezu Sarvestani

Certain of Boston Scientific's Cognis and Teligen implantable cardioverter defibrillators may fail prematurely due to battery issues, according to Australian and Chinese healthcare regulators.

Updated September 19, 2013, with comment from Boston Scientific.

Boston Scientific warns on batter issues in certain implantable defibrillators

Medical device maker Boston Scientific (NYSE:BSX) issued new warnings on its Cognis and Teligen implantable cardioverter defibrillators, advising physicians to watch out for premature battery depletion in older models.

The problematic implants are no longer available and haven't been manufactured since December 2009, according to a physician letter, but the devices may be subject a component issue that may diminish device performance after as little as 2 years, eventually depleting the battery entirely. All cases reported thus far have been detected by the implants' on-board diagnostic tools before the patients have experienced any symptoms, Boston Scientific said.

Sign up to get our free newsletters delivered right to your inbox.

"There have been no reported deaths associated with this issue," a company spokesman told MassDevice.com. "Boston Scientific has voluntarily notified the FDA and is alerting physicians of the issue. There are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring, described in the device labeling."

Comments