TUESDAY, April 25 (HealthDay News) -- Implantable cardioverter-defibrillators (ICDs) have a significantly higher malfunction rate than pacemakers and replacement of the defective devices can cause serious complications, including infections and death, according to two studies in the April 26 issue of the Journal of the American Medical Association.
William H. Maisel, M.D., of Harvard Medical School in Boston, and colleagues analyzed manufacturers' pacemaker and ICD annual reports from 1990-2002. Of the 2.25 million pacemakers and 415,780 ICDs that were implanted, 8,834 pacemakers and 8,489 ICDs were explanted due to malfunction, resulting in a malfunction replacement rate of 4.6 per 1,000 implants for pacemakers and 20.7 for ICDs. Battery malfunctions and electrical issues accounted for half of the device failures.
Paul A. Gould, Ph.D., of the University of Western Ontario, and a colleague studied the complications linked to elective ICD generator replacement in 17 Canadian implanting centers. About 8 percent of patients experienced complications within a 2.7-month mean follow-up, with 5.8 percent requiring reoperation and two patients dying.
"These investigations contribute important new data�about these devices," states the author of an accompanying editorial. "The information�should help physicians, patients, manufacturers and regulators make the best possible decisions for individual patients and for society."