Defibrillator malfunctions on the upswing

NEWS IN BRIEF — Posted Oct. 10, 2005

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An FDA study found that implantable cardiac defibrillator malfunctions serious enough to require replacements have gone up since the mid-1990s. Agency researchers examined ICD and pacemaker malfunctions between 1990 and 2002 and found that annually 20.7 out of every 1,000 ICDs had to be replaced. The study found that 4.6 out of every 1,000 pacemakers needed replacing.

The ICD-replacement rate trended down during the first half of the 1990s, the FDA's report said, but then climbed again with more than 50% of the malfunctions occurring between 1999 and 2002. Pacemaker or ICD malfunctions were directly responsible for 61 deaths, according to the agency. The study tracked more than 400,000 ICDs and 2.25 million pacemakers. Researchers speculated that ICDs' smaller size may have caused more battery, capacitor and circuitry problems.

Note: This item originally appeared at

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