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October 24th, 2007. Distribution of two types of defibrillators, Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds), is being suspended by Medtronic as a result of lead fractures. If a lead fractures, defibrillators may deliver unecessary shocks or may not function at all. Issues with the leads was first ... [More >>]
October 22nd, 2007. (Press Release) Statement by Daniel Schultz, M.D., director of the Center for Devices and Radiological Health: Medtronic's decision to voluntarily remove its Sprint Fidelis defibrillation leads from the market is in the best interest of patient safety. These electronic wires are prone to fracture in a small number of patients which ... [More >>]
October 19th, 2007. (Press Release) On Monday, October 15, Medtronic, Inc. said voluntarily suspended worldwide distribution of the Sprint Fidelis® family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949). The Sprint ... [More >>]
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