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Tracy Hampton, PhD

JAMA. 2005;294:2564.

	Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings.

The number of malfunctioning pacemakers removed and replaced in patients decreased from 1990 to 2002, while the number for implantable cardioverter defibrillators (ICDs) increased, according to a retrospective review by the US Food and Drug Administration (http://www.fda.gov/cdrh/ocd/icd/). The agency noted that while the reasons for the increased malfunction rate in ICDs have not been determined, they may be due to increased device complexity or more frequent reporting by physicians.

The annual malfunction replacement rates were 20.7 per 1000 ICDs and 4.6 per 1000 pacemakers. The pacemaker rate decreased over the study period; the ICD rate decreased during the first half of the study from a high of close to 40 replacements per 1000 devices to less than 10 per 1000 but increased again to nearly 40 replacements per 1000 devices during the second half.

While most of the malfunctions did not lead to death or . . . [Full Text of this Article]