During the summer of 2005, in the wake of widespread criticismof its failure to communicate the potentially fatal malfunctionsof its implantable defibrillators,1,2 Guidant Corporation createdan independent panel, of which we were members. The purposeof the panel was to conduct an unbiased examination of theseincidents, including the methods used to identify the malfunctionsand evaluate products in the post-marketing phase and the policiesregarding communication within the corporation and with physiciansand patients. The panel was also asked to recommend correctiveactions. Concurrently, the Heart Rhythm Society — whichrepresents physicians who implant cardiac devices — . . . [Full Text of this Article]
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Dr. Myerburg is a professor of medicine and physiology at the University of Miami Miller School of Medicine, Miami. Dr. Feigal is a partner at NDA Partners, Phoenix, Ariz., and the former director of the Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md. Dr. Lindsay is an associate professor of medicine and director of cardiac electrophysiology at Washington University School of Medicine, St. Louis.
This article was published at www.nejm.org on May 15, 2006.
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