FDAnews
www.fdanews.com/articles/68671-medtronic-to-issue-icd-warning-to-doctors

Medtronic to Issue ICD Warning to Doctors

February 11, 2005

Medical devicemaker Medtronic has begun warning doctors about some faulty batteries installed in a line of its implantable heart defibrillators.

The problem involves batteries in its Marquis line of implantable cardioverter defibrillators, or ICDs, made before December 2003. ICD batteries typically last for several years. The Medtronic problem involves batteries that can lose all power in just a matter of days.

The company said the battery problems occurred in only nine patients out of 87,000 worldwide. Medtronic will send out "Dear Doctor" letters giving details of the problem to physicians who have implanted the devices. Medtronic said no patients have been harmed by the battery problem. The company reported all nine events to the FDA.

(http://www.fdanews.com/pub/ddl)