Pacemakers malfunction less often than defibrillators

AORN Journal, Nov, 2005

Aretrospective review of implantable cardioverter defibrillator (ICD) and pacemaker malfunctions occurring between 1990 and 2002 found that overall the number of malfunctioning pacemakers removed and replaced in patients has decreased but the numbers for ICDs have increased, according to a Sept 16, 2005, news release from the US Food and Drug Administration. 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 physicians to return explanted devices to companies for analysis and to report adverse events.

Between 1990 and 2002 approximately 2.25 million pacemakers and 416,000 ICDs were implanted in the United States, and 17,323 devices (ie, 8,834 pacemakers, 8,489 ICDs) were removed from patients as a result of confirmed device malfunction. The annual ICD malfunction replacement rate of 20.7 per 1,000 implants was significantly higher than the pacemaker malfunction rate of 4.6 replacements per 1,000 implants. The pacemaker malfunction replacement rate decreased significantly during the study, in contrast to the ICD malfunction replacement rate, which trended down during the first half of the 1990s 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.

Pacemaker or ICD malfunctions were directly responsible for 61 confirmed deaths out of the nearly three million devices implanted between 1990 and 2002. The vast majority of reported malfunctions did not lead to death or serious injury, however, and were detected in time to ensure that patients would continue to receive therapy when it was needed.

FDA Releases Results of Study on Defibrillator and Pacemaker Malfunctions (news release, Rockville, Md: US Food and Drug Administration, Sept 16, 2005).