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U.S. Department of Health and Human Services

Safety

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Medtronic Implantable Defibrillator models

Audience: Cardiologists and other healthcare professionals

Medtronic, Inc. and FDA advised physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models. In a letter to physicians, Medtronic reported that batteries have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths. Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis™ VR/DR and Maximo™ VR/DR ICDs and the InSync I/II/III Marquis™ and InSync III Protect™ CRT-D devices.

[February 11, 2005 - Press Release - Medtronic, Inc.]