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FDA Report Addresses Heart Device Malfunctions

September 19, 2005
Under fire for the pace of its reaction to problems with some heart devices, the Food and Drug Administration has released a review of malfunctions of implantable cardioverter defibrillators and pacemakers occurring from 1990-2002.

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The agency said the study is part of its effort to improve the medical information it makes available from routine surveillance reports that the agency receives as part of its post market safety monitoring.

Overall, the study found that the number of malfunctioning pacemakers removed and replaced in patients has decreased, while the number of ICDs has increased. The FDA said the reasons for the increase in ICD malfunction rates have not been established, but potentially could relate to the increased complexity of these devices, manufacturing challenges posed by device complexity, or increased reporting by physicians.

The study also concluded that careful monitoring of device performance is needed, along with better ways for doctors to return explanted devices to companies for analysis and to report adverse events.

"The FDA is committed to continuing to improve the quality of information that patients and doctors have to make decisions about the safe and effective use of these critical, life-saving technologies," said Scott Gottlieb, MD, FDA Deputy Commissioner for Scientific and Medical Affairs.

From 1990 to 2002, the report says there were approximately 2.25 million pacemakers and 416,000 ICDs implanted in patients in the United States. During the same time period, 17,323 devices (8834 PMs and 8489 ICDs) were removed from patients due to confirmed device malfunction.

The agency says the PM malfunction replacement rate decreased significantly during the study. In contrast, the ICD malfunction replacement rate trended down during the first half of the 1990's but increased during the latter half of the study. In addition, more than 50% of the ICD malfunctions occurred during the last three years of the study. PM or ICD malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted during this time period.

"It is important for patients to understand that there is no action that they need to take as a result of this report. It does alert FDA that there is a trend that needs to be addressed and points out the need for our agency to improve the way it regulates these products, and we are doing just that," said Daniel Schultz, MD, Director of FDA's Center for Devices and Radiological Health.

The findings were presented at the Heart Rhythm Society "Policy Conference on Pacemaker and ICD Performance," in Washington, DC.

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