FDA Warns of Premature Battery Depletion in Some Medtronic Pacemakers

The U.S. Food and Drug Administration on Tuesday said it issued an alert about the potential for the batteries of certain Medtronic PLC (MDT) implantable pacemakers to drain more quickly than expected and without warning to patients.

The agency said it is aware of three events related to the issue, including one that resulted in the death of a pacemaker-dependent patient.

The FDA said about 132,000 of the devices have been sold in the U.S., adding that it isn’t currently recommending removal and replacement of the pacemakers due to the low frequency of device failure. Instead, the agency said patients and physicians should carefully monitor the battery status of the devices using home monitoring systems.

The alert covers several models of Medtronic’s Azure, Astra, Percepta, Serena and Solara pacemakers. The FDA said it recently approved improvements to Medtronic’s manufacturing process and a new component for newly made pacemakers.

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