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
February 15, 2005