FDA: Certain Medtronic pacemaker, CRT-P batteries can fail without warning

The FDA issued an alert May 7 warning patients with certain implanted Medtronic pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) and their care teams to check for premature battery depletion in their devices after defects resulted in three reports and one patient death.

The agency said it received three medical device reports to date in which a Medtronic pacemaker or CRT-P battery fully drained because of a crack in the device’s capacitor, shutting the device down without any warning to the patient or their healthcare providers. If a pacemaker’s capacitor—a device component that stores electrical energy—cracks, it can trigger an electric short, causing the battery to drain faster than expected and bringing a halt to the patient’s pacing therapy.

In all three cases, Medtronic reported healthcare providers were unable to communicate with their patients’ devices due to battery depletion. The events occurred an average of seven months after pacemaker or CRT-P implantation, even though Medtronic’s devices are designed to last anywhere from four to seven and a half years without a battery replacement.

In one report, a patient experienced dizziness during a follow-up visit with their physician, who was unable to communicate with the device and identified the issue. In another, a healthcare provider noticed the problem before implanting the device, but in the final case, a pacemaker-dependent patient died because their device ceased to function.

The Medtronic alert said five pacemaker and CRT-P device models are affected by the glitch, including Azure, Astra, Percepta, Serena and Solara models. As of April 10, 131,889 of the devices had been sold in the U.S.

In the alert, the FDA said Medtronic recently received agency approval for a new step in its pacemaker and CRT-P manufacturing process that would better catch capacitor failures. The FDA also said the company was cleared for a different capacitor designed to reduce the risk of rapid battery depletion in new devices.

For now, the FDA recommended healthcare providers encourage their patients to continue using their remote monitors, advising against prophylactic removal and replacement of devices unless it’s necessary for survival. The agency said physicians should replace a patient’s pacemaker or CRT-P immediately following an elective replacement indicator (ERI) alert—a notification that tells patients when their battery level drops below a certain limit.

The FDA said there’s no way to accurately know how much battery life is left in affected devices after an ERI alert, but it’s likely lower than the standard three months.

“Treat pacemaker-dependent patients with a device that has reached ERI as a medical emergency,” the agency wrote.

For patients and caregivers, the FDA suggested keeping their remote monitors plugged in at all times, monitoring their linked MyCareLink Heart App on their smartphones, seeking medical help if they feel lightheaded, dizzy or have chest pain, and talking to their physicians about whether their specific device could be affected by the alert.

“The FDA will continue to work with Medtronic to monitor affected pacemakers and CRT-Ps for any adverse events related to premature battery depletion,” the agency said, noting they’d keep the public informed of any updates.

Find a full list of affected Medtronic devices here.