ICD MALFUNCTIONS ON THE RISE, ACCORDING TO FDA ANALYSIS
Implantable cardioverter defibrillators (ICDs) are malfunctioning at an alarmingly high rate, according to a new FDA analysis.
The analysis, conducted by Harvard University medical professor William Maisel, indicates that ICD malfunctions requiring surgical replacement increased from 7.9 per 1,000 devices in 1998 to 38.6 in 2001, before falling to the mid-20s by 2002, the last year examined. Of the approximately 416,000 ICDs implanted in the U.S. from 1990 to 2002, roughly 8,500 were removed from patients due to confirmed device malfunction, the data shows.
Maisel, who chairs the FDA's Circulatory System Devices Advisory Panel, presented his analysis at a recent conference in Washington, D.C. The meeting, organized by the FDA and the Heart Rhythm Society, was called in response to the recent controversy over how Guidant disclosed problems with some of its ICDs.