Guidant INSIGNIA and NEXUS Pacemakers Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers Guidant VENTAK PRIZM 2, VITALITY and VITALITY 2 Implantable Cardioverter Defibrillators

Published: Tue Jun 26 00:00:00 -0400 2007

Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators is associated with five reports of device malfunction due to the failure of a low-voltage capacitor from a single component supplier. Patients with affected pacemakers may experience intermittent or permanent loss of output or telemetry or premature battery depletion. Patients with affected ICDs may experience inappropriate sensing or premature battery depletion. Physicians are asked to perform an exam as soon as possible to assess device function for all patients with implanted devices from this subset.