FDA Warns of Premature Battery Depletion With Certain ... | 合法醫療器材資訊網

2019年5月7日—...prematurebatterydepletionwithMedtronicimplantablepacemakersor...theMedtronicpacemakerorCRT-Pbatteryfullydrainedbecauseof ...

The US Food and Drug Administration is issuing a safety communication informing patients and health professionals about the potential for premature battery depletion with Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-P).

To date, there have been three medical reports where the Medtronic pacemaker or CRT-P battery fully drained because of damage to the device’s capacitor. One patient died as a result of the damaged device and another patient experienced dizziness in follow-up that led to device replacement.

“If a capacitor in an implanted pacemaker or CRT-P is cracked, it can create an electric short, which can cause a battery to drain earlier than expected,” according to the FDA. “If the battery is completely drained, the device will no ...