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News From the Food and Drug Administration
June 18, 2019

Safety Alert for Certain Pacemakers

JAMA. 2019;321(23):2274. doi:10.1001/jama.2019.7980

An FDA safety communication has warned clinicians and patients that batteries may suddenly drain in some Medtronic implantable pacemakers and cardiac resynchronization therapy pacemakers (CRT-P). Affected devices include select Azure, Astra, Percepta, Serena, and Solara models.

Pacemaker batteries are designed to last between 6 and 15 years, depending on the device and amount of pacing. However, capacitors in these pacemakers may crack, creating an electrical short that can cause the battery to drain prematurely, without warning. Among the 3 reports the agency has received, battery issues occurred on average 7 months after the device was implanted and resulted in 1 patient’s death.