FDA Warns of Premature Battery Depletion in Some Medtronic ... | 合法醫療器材資訊網

2019年5月7日—FDAsafetycommunicationissuedafterMedtronicidentifiedararebutpotentiallyseriousfailuremodeinseveralpacemakerscontributingto ...

May 7, 2019 — The U.S. Food and Drug Administration (FDA) issued a safety communication to alert healthcare providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers[1] or cardiac resynchronization therapy pacemakers (CRT-Ps)[2] to drain more quickly than expected without warning.

Medtronic Pacemaker Battery Depletion Issue Identified

Medtronic has identified a rare but potentially serious failure mode in some of its Azure and Astra pacemakers, and Percepta, Serena and Solara cardiac resynchronization therapy pacemakers (CRT-P), manufactured with a specific multilayer ceramic capacitor. The company said these electrophysiology (EP)[3] devices continue to perform within reliability projections.  

Implanted pacemakers and CRT-Ps have electronics and are powered by lithium-ion batter...