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FDA Supports Defibrillator Recall



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Dr. Kim Mulvihill reportingThe FDA says it is supporting a company-initiated recall of implantable defibrillators.

The company , Guidant Corporation, says some of it's implantable defibrillators may malfunction without warning.

Implantable Cardiac Defibrillators - or ICD's- save lives. It's like carrying around a paramedic or an emergency room in your pocket. But so far 45 devices have failed and there have been two deaths due to malfunction.

When vice president Dick Cheney went to the hospital almost four years ago, most Americans learned about ICD's or implantable cardiac defibrilators for the first time.

This high tech device, which is implanted under the collarbone and wired into the heart, packs a punch for hearts with rhythms that beat abnormally.

Today a top manufacturer, Guidant Corporation, voluntarily recalled several of its ICD's, including the Ventak prism 2 DR. The recall is linked to a potential flaw where some could short circuit and not work at all.

So if you have one of those models, don't panic. Experts say there is no immediate danger. But what you need to do is talk to your doctor.

For any given patient there are numerous ways to handle this. Everything has to be individualized based on the particular patient.

Recalls linked to ICD's are not uncommon. But studies show these devices save lives. And, with heart disease still the number one killer of Americans, experts expect millions of these devices will be implanted as baby boomers age.

According to the FDA patients should contact their doctor immediately if they feel an electrical shock from their device -- or if there is an audible beeping coming from the device. It may mean the defibrillator could be damaged.

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