FDAnews Device Daily Bulletin

Australia’s TGA Issues Alerts for Medtronic Defibrillators

Jan. 20, 2017

Australia’s Therapeutic Goods Administration has issued safety alerts for Medtronic Australasia’s cardiac re-synchronization therapy defibrillators (CRT-Ds).

CRT-Ds are implantable medical devices that deliver electrical impulses to treat abnormal heart rhythms. The devices can be reprogrammed using external controllers. Medtronic said it has received two reports of patients outside of Australia losing therapy in their left ventricles following a particular sequence of reprogramming commands. — Jeff Kinney

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