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Guidant pacemaker models might need replacement

INDIANAPOLIS - Guidant Corp., already under fire for problems with its implantable defibrillators, on Monday warned physicians that replacements might be needed for nine pacemaker models made from 1997 to 2000.

The safety advisory, which affects 28,000 devices in use worldwide, heightened concerns among heart patients and raised new questions about the wisdom of a planned $25.4-billion acquisition of Guidant by Johnson & Johnson of New Brunswick, N.J.

The Indianapolis-based company said a sealing component in the pacemakers has degraded in some cases, resulting in higher-than-normal moisture in the devices and possible malfunction.

Guidant distributed about 78,000 pacemakers, about 18,000 of which are still in use in U.S. patients. The devices, which send electrical pulses to the heart to accelerate a slow heartbeat, have a seven- to 10-year life span before they must be replaced.

The company said it has identified 69 failures among the pacemakers - all after they had been used for at least 44 months.

Several patients have lost consciousness or developed possible heart failure, the company said. The statement reported the death of one person whose pacemaker may have failed, but Guidant said the device was not returned for testing and its role could not be confirmed.

Guidant said it would replace the devices, which are about the size of two half dollars held together, at no charge through the end of the year, even though the warranty on many has expired. Guidant will also reimburse patients up to $2,500 for medical expenses. Pacemakers are implanted in a short surgery through an incision near the shoulder.

Food and Drug Administration spokeswoman Julie Zawisza said the agency was evaluating Guidant's warning. Guidant said the FDA might classify the warning as a recall.

The company recalled 11 defibrillator models last month because of faulty mechanisms, which resulted in two deaths. About 88,000 of the devices remain implanted worldwide.

Defibrillators shock the heart when it beats too quickly. They are three times the size of pacemakers and require surgery similar to pacemakers for implantation.

Dr. Angel Leon, chief of cardiology at Emory Crawford Long Hospital in Atlanta, said the safety warning poses less risk for patients than the defibrillator recalls. That's because of the relatively small number of pacemakers implanted and because the deterioration occurs gradually, allowing patients more time to seek help.

"These device recalls have been happening for years," he said. "By no means do they suggest these companies are making bad products. It's how they handle the recalls that's important. I think they've learned a big lesson here."

[Last modified July 19, 2005, 01:09:13]