Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
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(tm) VR/DR and Maximo(tm) VR/DR
ICDs and the InSync I/II/III Marquis(tm) and InSync III Protect(tm) CRT-D
devices.
Read the complete MedWatch 2005 Safety Summary, including a link to the Firm
Press Release:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ICD
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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(tm) VR/DR and Maximo(tm) VR/DR
ICDs and the InSync I/II/III Marquis(tm) and InSync III Protect(tm) CRT-D
devices.
Read the complete MedWatch 2005 Safety Summary, including a link to the Firm
Press Release:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#ICD
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