ICD and Pacemaker Malfunctions

Pacemakers and implantable cardioverter-defibrillators (ICDs) are becoming much more prevalent, prompting Maisel and colleagues to review FDA annual reports of malfunctions submitted by device manufacturers from 1990 to 2002. Malfunctions were defined as situations in which a device was explanted after an observed malfunction, returned to the manufacturer, and then confirmed by the manufacturer to be malfunctioning. Deaths were attributed to device malfunction only if the malfunction immediately led to a witnessed death and the manufacturer subsequently confirmed the malfunction.

Of 2.25 million pacemakers and 415,780 ICDs implanted, 8834 and 8489, respectively, malfunctioned. Most malfunctions (80%) were due to hardware abnormalities, most …