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Pacemaker and ICD Generator Malfunctions

William H. Maisel, MD, MPH; Megan Moynahan, MS; Bram D. Zuckerman, MD; Thomas P. Gross, MD, MPH; Oscar H. Tovar-Calderon, MD; Donna-Bea Tillman, Ph.D., Daniel B. Schultz, MD

BACKGROUND – Pacemakers (PM) and implantable cardioverter-defibrillators (ICDs) are complex medical devices clinically proven to reduce mortality in specific high-risk patient populations. However, the devices occasionally malfunction. This study analyzed manufacturer PM and ICD FDA post-approval annual reports to determine the reported number and rate of PM and ICD malfunctions and to assess trends in device performance.

METHODS – PM and ICD annual reports submitted to FDA for the years 1990-2002 were reviewed. Each report contains the number of implanted devices and detailed information concerning device malfunctions. A PM or ICD generator malfunction was defined as a device that was: 1) explanted due to malfunction, 2) returned to the manufacturer, and 3) confirmed by the manufacturer to be functioning inappropriately. To calculate PM and ICD generator malfunction replacement rates, it was assumed that malfunctioning devices that were explanted from living patients were replaced with new devices.

RESULTS – From 1990 to 2002, there were ~2.25 million PMs and ~416,000 ICDs implanted in the United States. During the same time period, 17,323 devices (8834 PMs and 8489 ICDs) were explanted due to confirmed device malfunction. The annual ICD malfunction replacement rate (mean [SE]) was significantly higher than the PM malfunction replacement rate (20.7 [3.2] vs. 4.6 [0.6] replacements per 1000 implants; P<0.001). 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 markedly during the latter half of the study. In addition, more than 50% of the ICD malfunctions occurred during the last 3 years of the study. PM or ICD malfunctions were directly responsible for 61 confirmed deaths.

CONCLUSIONS – This study demonstrates that: 1) thousands of patients have been affected by PM and ICD malfunctions, 2) the malfunction replacement rate for ICDs is significantly higher than that for PMs, and 3) the ICD malfunction replacement rate appears to be increasing. PMs and ICDs are important life-sustaining devices that have saved many lives. Careful monitoring of device performance is still required.

From: Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA (WHM) and Food and Drug Administration, Center for Devices and Radiologic Health, Rockville, MD (MBM, BDZ, TPG, OHTC, DBT, DBS).

Updated September 16, 2005

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