ICD, pacemaker malfunctions may pose risks to patients
Pacemakers and implantable cardioverter-defibrillators (ICDs) have been proven to save lives. However, a recent study published in the Journal of the American Medical Association found that malfunctions have affected thousands of people, requiring removal of the devices and leading to some deaths. Researchers analyzed annual reports submitted to the U.S. Food and Drug Administration from 1990 to 2002. Of the 2.25 million pacemakers and 415,780 ICDs implanted during the study period, 8,834 pacemakers and 8,489 ICDs were removed due to confirmed malfunctions, most commonly battery/capacitor (generator) abnormalities. Device malfunctions were directly responsible for 61 deaths (30 pacemaker patients and 31 ICD patients). The annual mean malfunction replacement rate for ICDs (20.7 replacements per 1,000 implants) was considerably greater than that of pacemakers (4.6 replacements per 1,000 implants), according to the study. The researchers also found that, while the number of pacemaker malfunctions decreased during the study period, the yearly number of ICD malfunctions rose. The fact that ICDs are more sophisticated than pacemakers may explain their greater malfunction rate, the researchers wrote. Despite the malfunctions, the researchers note that pacemakers and ICDs “remain an important therapy for patients at high risk for sudden cardiac death,” and they recommend that patients seek routine device checks at regular intervals from their physicians.
Another study published in JAMA found that patients undergoing ICD generator replacement for recalled devices face a substantial risk of complications, including death. Malfunctions have resulted in government recalls (advisories) of some ICDs, prompting some patients and their physicians to choose device replacement as a solution. Canadian researchers examined 2,915 patients who had recalled ICDs, including 533 who underwent replacement of the device an average of 26.5 months after the initial ICD implantation. Thirty-one (5.8 percent) of these patients suffered major complications, resulting in 2 deaths, while 12 others experienced minor complications. The researchers wrote that any guidelines for the treatment of patients with recalled devices must consider the potential risks associated with ICD generator replacement.
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