GUIDANT DEFIBRILLATORS RECALL & SETTLEMENT

Short Circuit Risk Prompts FDA to Recall Guidant Defibrillators

FDA has notified health care providers and patients that the Guidant Corporation is recalling certain of its implantable defibrillators and cardiac resynchronization therapy defibrillators. These devices can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed.

The devices affected by this notification are:

• PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
• CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
• CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

Guidant has also recently informed the FDA that it is recalling another set of defibrillator devices called PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance.

The Guidant defibrillators are implanted into the chest cavity of patients and are intended to monitor irregularities in heart rhythm (arrhythmia). When functioning properly the units can detect when the heart is beating out of rhythm, and deliver a series of electrical shocks to correct the arrhythmia.

Recalls linked to ICD's are not uncommon. There are approximately 50,000 patients in the United States with one of these recalled defibrillators. Guidant Corp. has said that the devices have malfunctioned at least 45 times, causing two deaths.

While medical technology has helped relieve the suffering of many people, the Institute of Medicine estimates that almost 1.3 million Americans are injured or die as the result of faulty medical products.

If you have one of the recalled Guidant defibrillators, contact your doctor immediately to discuss your medical options. FDA is not making a recommendation on whether individual patients who have one of the Guidant devices should have it removed and replaced. This is a decision that should be made by a patient in consultation with his or her physician, based on the specific medical situation of the patient. Removal and replacement of the device may pose some risk, so it is important that patients and physicians carefully discuss this matter before making a decision.

If you feel an electrical shock from a device, or if there is an audible beeping coming from the device, it may mean the defibrillator is damaged.

• FDA advises patients to take the following steps:
• If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
• Continue to keep your regular doctor appointments.
• If you feel an electrical shock from your device, immediately contact your doctor.
• If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

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