FDA has issued a Class I designation of a Medtronic (NYSE: MDT) recall involving 239,171 ICDs and CRT-Ds with potential battery life problems.
The agency reported 444 complaints regarding the devices: Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT-Ds) distributed from Aug. 31, 2012, to May 9, 2018.
Among 264 Medical Device Reports, there were 18 injuries, including people experiencing bradycardia (slow heart rhythm) or heart failure symptoms. There were no reports of deaths.
The devices’ problem involves a potential short circuit that could cause an unexpected and rapid decrease in battery life. The time between the first “Recommended Replacement Time” warning and full battery depletion could be as little as one day. However, a Medtronic spokesperson noted to MassDevice that the median time from RRT to end of service was 14 days.
Medtronic is no longer distributing the battery design involved with the problem, with no implants of ICDs and CRT-Ds affected by the issue since February 2019.
Medtronic sent an Urgent Medical Device Correction letter to all affected health care providers on Feb. 3. The medical device giant told physicians to continue normal follow-up per local clinical protocol, including reminding patients to contact their clinic if they hear an audible alert and to take advantage of the CareLink home monitoring system and the wireless low battery voltage CareAlert when possible. If someone observes an unexpected Recommended Replacement Time (RRT) warning, device replacement needs to take place promptly.
The company, in consultation with the Independent Physician Quality Panel, is not recommending prophylactic replacement.