Warning on Faulty Implanted Defibrillators

The manufacturer, Guidant Corp. (Indianapolis, IN, USA), is advising doctors worldwide of this development so they can decide how best to treat their patients.

The devices involved are the Ventak Prizm 2DR (model 1861) ICDs manufactured on or before April 16, 2002; the Contak Renewal (model H135) and Contak Renewal 2 (model H155), manufactured on or before August 26, 2004; and the Ventak Prizm AVT, Vitality AVT, Renewal 3AVT, and Renewal 4 AVT ICSs (all series).

The Prizm 2 and Renewal devices are subject to failures that result in the inability to deliver an electric shock during episodes of arrhythmia, which could lead to a serious, life-threatening event for a patient. Twenty-eight reports of failure have been reported worldwide in the Ventak Prizm 2 DR devices, including one death. Fifteen reports of failure mode have been confirmed in the Contak Renewal devices. Two deaths suspected to be associated with this malfunction have been reported to the U.S. Food and Drug Administration (FDA, Washington, DC, USA; www.fda.gov). Guidant recommends that doctors of patients with these devices should continue with normal follow-up visits at three-month intervals. If a decision is made to replace a device, Guidant will provide a replacement at no charge.

In addition, the company's Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT devices are subject to a memory error, which may affect available therapy. Guidant is recommending a programming change that can reduce the risk of this happening, a change that can be implemented at the next office visit a patient makes.

The FDA is considering this action of Guidant as a recall and is not making any recommendations at this time on whether individual patients who have one of the devices should have it removed and replaced. That is a decision that should be made by patients in consultation with their doctors. If patients feel an electrical shock from their device or hear an audible "beeping,” they should immediately contact their doctor.




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