FDA issues alert on premature battery depletion in certain Medtronic pacemakers

Editor's Note

The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic.

The FDA is aware of three patients in which a battery fully drained because of a crack in the capacitor, without any warning to the patients or healthcare providers. One of the patients died, one experienced dizziness and had the device replaced, and one patient was in the process of having the pacemaker implanted when the battery drained.

Medtronic has received FDA approval for a new step in the manufacturing process that will better detect capacitor failures and for a different capacitor to reduce the risk of rapid battery depletion.