FDA alerts providers of premature battery depletion in pacemakers

The FDA is alerting patients and health care providers about premature battery depletion without warning in several pacemakers and cardiac resynchronization therapy pacemakers by Medtronic.

The models affected by this battery issue include Azure, Astra, Percepta, Serena and Solara, according to a safety communication from the FDA. There have been 131,889 devices sold in the United States as of April 10.

The FDA has received three medical device reports in which the battery of an implantable pacemaker or CRT pacemaker fully drained due to a crack in the device’s capacitor. This crack can lead to an electric short, causing the battery to drain sooner than expected without warning and stop pacing therapy, according to the safety communication.

In the three reports received by the FDA, health care providers could not communicate with the device because of battery depletion, and these events occurred within 1 year after pacemaker implantation, according to the safety communication. One reported event resulted in the death of a patient. Another patient experienced dizziness during follow-up and, eventually, the pacemaker was replaced. The device in the third report was not implanted when the health care provider noticed that communication could not be established, resulting in no harm to the patient.

The FDA recommends that health care providers should not remove and replace affected devices, but rather consult with their patient whether replacement is appropriate for their needs, according to the safety communication. Health care providers should also be aware of the potential for battery depletion during remote transmissions and follow-up visits. Patients should be advised by health care providers to continue using their remote monitors. Devices with elective replacement indicator alerts should be replaced and should be treated as a medical emergency.

In addition, patients and caregivers should check that home monitoring transmissions are occurring at appropriate times and to always keep the remote monitor plugged in, according to the safety communication. Patients should also check the battery level on the mobile app (MyCareLink Heart, Medtronic). Immediate medical care should be obtained if the patient feels dizzy, lightheaded, severe shortness of breath, chest pain or if a caregiver sees someone with the device who had lost consciousness. Patients should also discuss with their health care providers whether they have an affected device and what actions should be taken.

The FDA will work with Medtronic to monitor for adverse events in patients with affected pacemakers and CRT pacemakers, according to the safety communication.

Specifications of the device models affected by this issue can be found on the FDA website.