Guidant Implantable Pacemakers

Boston Scientific/Guidant has confirmed five reports of Guidant Implantable Pacemaker and Defibrillator malfunction among some 27,200 patients worldwide in whom these devices were implanted. One malfunction occurred at the time of implantation. In four cases, the patients needed to have their Guidant Implantable Pacemaker or Defibrillator replaced. The patients lost consciousness in two of these cases. There are no reported deaths.

Boston Scientific/Guidant has identified certain lots of a supplier's low-voltage capacitor as the likely source of the problem. The affected products include certain models of the Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators. These devices were manufactured by the company's Cardiac Rhythm Management Group, formerly Boston Scientific/Guidant's CRM business, and implanted in patients between December 2005 and June 2006.

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