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Reliability of Pacemakers and Defibrillators to be Improved

kers and defibrillators first became headline news when the Guidant Corp. issued an alert saying that about 28,000 pacemakers had defects that could make them malfunction. In addition it was revealed that the company had decided not to issue alerts about life-threatening defects in some of its implanted defibrillators. Since then the U.S. Food and Drug Administration has increased its watch of such heart devices.

Maisel’s study found the annual replacement rate for pacemakers in the United States due to malfunction was 4.6 per 1,000 implants. For defibrillators, the rate was 20.7 per 1,000 implants. The annual replacement rate for pacemakers decreased steadily over the years, while the defibrillator replacement rate decreased from 1993 to 1996, and then rose sharply. More than half the defibrillator malfunctions occurred in the last three years of the study.

There were 30 deaths attributed to device failure from 1990 to 2002 among pacemaker patients and 31 among the much smaller number of defibrillator patients.

According to Maisel the study only calls for an ongoing monitoring of device performance. Industry needs to be reporting device performance in a more timely fashion, informing physicians and patients of malfunction.

At the same time, people who have the devices implanted need to have "a more realistic expectation of device performance," Maisel said
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