Boston Scientific warns on battery issues in certain implantable defibrillators

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.

"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."

The Massachusetts medical device giant asked physicians to continue normal patient care and observation and to take greater care with any alerts that pop up during routine monitoring. If the device does issue an alert, the usual 3-month window for replacement may be cut short by battery depletion, leading to poor device performance, the letter states.

The older model Cognis and Teligen devices have not been available for implant since November 2010, but there were an estimated 38,500 devices distributed that were found to be subject to higher than expected rates of malfunction (about 0.7%, or 1 in 150), according to a warning posted by China’s Dept. of Health.

Patients were warned to keep an ear out for any beeping from the implanted device, as the on-board Security Architecture system will raise an audible alarm if it detects battery issues, according to a notice from Australia’s Therapeutic Good Administration.

The new warnings are not the 1st time Boston Scientific has had issues with the Teligen and Cognis suite of devices. In April 2012 the device maker warned that 1 patient had died and others had suffered adverse events due to electrical malfunctions in the implants that the company called "an identifiable pattern of malfunction". Boston Scientific also warned on the devices in December 2009, citing connection problems on pacemakers implanted beneath the pectoral muscles. Another warning issued in March 2009 advised doctors to watch out for “inappropriate” shocks caused by faulty wiring in some of the devices.

Boston Scientific did not immediately respond to a request for comment.

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