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August 24/31, 2005

Safety Issues Involving Medical DevicesImplications of Recent Implantable Cardioverter-Defibrillator Malfunctions

Author Affiliations

Author Affiliation: Cardiovascular Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Mass.

JAMA. 2005;294(8):955-958. doi:10.1001/jama.294.8.955

This past spring, Joshua Oukrop, a 21-year old Minnesota college student with familial hypertrophic cardiomyopathy, died of cardiac arrest when his implantable cardioverter-defibrillator (ICD) short-circuited and failed to resuscitate him.1 Guidant Corporation (Indianapolis, Ind), the maker of his ICD, was aware of the potential for this type of malfunction, having observed 26 similar failures out of 37 000 devices.1,2 The company, however, decided not to notify physicians of the flaw for more than 3 years after first detecting it.1,2 As implantations of complex electrophysiological devices become increasingly commonplace, the number of patients affected by defective devices can be expected to increase. Understanding the history of medical device regulation, the benefits and limitations of technology, the obligations of manufacturers, the expectations of physicians and patients, and the responsibilities of national physician and industry organizations can provide a framework for improving the medical device reporting and notification systems.

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