June 27 , 2006

FDA ALERT

Guidant implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators: reports of malfunction

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators [ICDs] is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. Physicians are asked to perform an exam as soon as possible to assess device function for all patients with implanted devices from this subset.

Read the complete MedWatch 2006 Safety summary, including links to the firm press release, and the Guidant letters to physicians and patients,
at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#Guidant