Faulty defibrillators may mean surgery for thousands of cardiac patients

Jun 20 2005

Surgery to replace possibly faulty implanted cardiac defibrillators may now be on the cards for thousands of cardiac patients.

The recall, by manufacturer Guidant of about 50,000 of the devices was announced on Friday and follows the deaths of two patients and at least 45 failures of the devices.

Indianapolis company Guidant and the Food and Drug Administration (FDA) did not recommend that the devices be removed or replaced.

Guidant and FDA officials say patients should continue normal visits to their doctors, but patients who recently received a defibrillation shock from their device should check with their doctors.

Defibrillators are implanted in cardiac patients to sense and correct an irregular heartbeat and are installed below the collarbone with wires running to the heart.

Guidant and the FDA said the recall involves approximately 29,000 devices that might develop a short circuit where they fail to deliver a shock when needed. These are the Ventak Prizm 2 DR and Contak Renewal models. Of these, about 20,600 are in use in the USA.

Guidant said it would provide free replacements for patients seeking them.

Another 21,000 devices that could fail because of computer memory problems are the Ventak Prizm AVT, Vitality AVT and Renewal AVT devices. About 18,000 are implanted in the USA.

For these, Guidant is recommending a programming change.

Although doctors expect Guidant patients to call and crowd waiting rooms, Kenneth Ellenbogen, cardiac electrophysiologist at Virginia Commonwealth University School of Medicine says they do not expect to replace devices in most patients because the risk of failure is "very, very rare," and may be less than the risk of replacement.

Gregory Lewis of West Suburban Cardiologists in Chicago says the most likely candidates for replacements are the minority of patients who also rely on the devices to keep their hearts beating.

Jeffrey Olgin, cardiac electrophysiologist at the University of California, San Francisco, says he is still assessing the information but says he doesn't expect to recommend replacement for most of his patients.

The recall comes just as health care giant Johnson & Johnson continues with it's plans to acquire Guidant, in part to gain access to its defibrillator line.

The $25.4 billion deal was announced in December.

Johnson & Johnson says it is continuing to work toward a close of the purchase, but regards the events reported by Guidant as serious matters, and they are attempting to better understand the situation.