FDA Alert Says Some Medtronic Pacemaker Batteries Can Fail Without Warning

May 07, 2019

Two dozen Medtronic pacemaker models in the Azure, Solara, and other product lines are the subject of a safety alert from the US Food and Drug Administration (FDA), which warns they could fail suddenly because of premature battery depletion.

The alert covers almost 132,000 conventional pacemakers and biventricular pacemakers for cardiac resynchronization therapy (CRT-P) from the company sold in the United States, the agency said.

The FDA has received reports of three such Medtronic devices in which the battery "had fully drained because of a crack in the device's capacitor, without any warning to the patient or healthcare provider."

Providers "were unable to communicate with the device due to battery depletion, resulting in loss of pacemaker function."

As a result, one patient who was pacemaker-dependent died, another who experienced dizziness when the device failed had it successfully replaced, and a third was unaffected as the failure was detected before implantation, the agency said.

The alert lists the models affected, which include six in each of the Azure and Astra lines, and four in each of the Percepta, Serena, and Solara product lines.

Azure, Percepta, Serena, and Solara devices may be monitored remotely for the problem via Medtronic's CareAlert system. Patients with Astra pacemakers, which don't have wireless capability, must ensure they transmit to CareAlert on schedule, the agency cautions.

Prophylactic replacement of the affected devices as a matter of course is not recommended, although clinicians may decide on a case-by-case basis that removal and replacement is appropriate for some pacemaker-dependent patients, it says.

Otherwise, "be aware of sudden battery level drops during follow-up visits and remote transmissions. Watch for decreases in battery level out of proportion to the life of the device from the time of implant even if the level remains within the normal range."

Although a device that sends elective replacement indicator (ERI) notification to patients and providers through CareAlert would normally have about 3 additional months of function, affected devices would be unlikely to last that long, the FDA says.

"Treat pacemaker-dependent patients with a device that has reached ERI as a medical emergency."

Safety Communication: FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication

Media Announcement: FDA In Brief: FDA issues alert on potential premature battery depletion of certain Medtronic implantable pacemakers, approves related enhancements to device

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