Life-Threatening Malfunction of Implantable Cardiac Devices

During the summer of 2005, in the wake of widespread criticism of its failure to communicate the potentially fatal malfunctions of its implantable defibrillators,1,2 Guidant Corporation created an independent panel, of which we were members. The purpose of the panel was to conduct an unbiased examination of these incidents, including the methods used to identify the malfunctions and evaluate products in the post-marketing phase and the policies regarding communication within the corporation and with physicians and patients. The panel was also asked to recommend corrective actions. Concurrently, the Heart Rhythm Society — which represents physicians who implant cardiac devices . . .