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U.S. Department of Health and Human Services

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Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers

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

Audience: Cardiac healthcare professionals, risk managers and biomedical engineers

[Posted 06/26/2006, UPDATED 07/11/2006] Guidant and FDA notified healthcare professionals and patients that a subset of implantable pacemakers, cardiac resynchronization therapy pacemakers and implantable cardioverter defibrillators [ICDs] 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.

[April 10, 2007 - Questions & Answers - FDA]
[July 11, 2006 – FDA Statement – FDA]
[June 26, 2006 – Press Release – Boston Scientific/Guidant]
[June 23, 2006 – Letter to Physicians – Guidant]
[June 23, 2006 – Letter to Patients – Guidant]