John Heller, Post-Gazette
	Kathleen Novak shows the scar where her new defibrillator was placed three weeks ago at UPMC.

Four years ago, Kathleen Novak jolted out of a sound sleep, yelling loud enough to wake her brother in the bedroom down the hall. A defibrillator implanted in her chest had zapped her heart, which had been on the verge of killing her with a beat gone haywire.

Novak counted herself lucky. A similar haphazard rhythm, the result of a disease that thickens the heart muscle, was probably why her father and a brother died in their sleep.

Last month, she got a shock of a different kind. She found out that Guidant Corp., the company that made the device keeping tabs on her heartbeat and standing by to rescue her, was recalling some models. A flaw could make them fail to deliver a necessary shock.

"I was very concerned," said Novak, 55, of Seneca, Venango County. "I feel absolutely dependent on my defibrillator."

She called her doctors and Guidant, confirming that her model was indeed on the recall list.

"It's definitely a big problem," said Dr. Samir Saba, director of the cardiac electrophysiology laboratory at the University of Pittsburgh Medical Center, where "more than 450 patients are involved in one way or the other by the recall."

About 160 will have their devices replaced and less than a third of those surgical procedures have been done, he said.

Doctors at Allegheny General Hospital will replace defibrillators in a small number of their 260 patients who were affected by the recalls. Most have the kind of units that can be repaired with reprogramming, said spokesman Dan Laurent.

Guidant's handling of the situation has upset doctors and left many patients confused and fearful that the devices implanted in their chests will fail when they need them most.

At first, Novak thought the fact that her defibrillator functioned properly once meant it was fine.

	Steve Mellon, Post-Gazette
	Dr. Samir Saba -- "Part of the frustration has been ... with the way the information has been released in bits and pieces. It creates a communication problem between us and our patients."

Then she learned that "having worked in the past was no guarantee that it would work in the future," she said. "The fault did not necessarily happen the first time or every time."

Novak didn't get much sleep after that.

"I was on the Internet some late nights," she said. "I was very tense and worried during the month before I got it replaced, that I would have need of it and it wouldn't come through for me."

Saba said the odds of a malfunction are quite low and must be weighed against the small risk of complications during surgery to replace the unit.

The patient's medical history, the model type and personal preference must be factored into the decision, he said.

Those who have needed a lifesaving shock in the past are more likely to be encouraged to get a new device, but all patients who have a potentially flawed defibrillator have to see their doctors to discuss their options.

Novak got a new unit about three weeks ago. In the outpatient procedure, doctors remove the body of the device and reconnect the replacement to the same wires.

She can already feel it correcting some abnormal beats. If her heart rhythm becomes erratic to the point of threatening her life, the defibrillator will deliver a shock that feels like being "kicked in the chest by a mule with spiked shoes," she said.

"I feel much calmer about it, even though it was no fun doing [the replacement procedure] and I'm black-and-blue," Novak said. "I'm very happy to have it over with."

Guidant knew of risks
But the scrutiny of Guidant and other defibrillator makers may be just getting under way.

In May, the New York Times said the Indianapolis corporation sold a defibrillator model it knew had a small risk of malfunctioning, but didn't issue warnings about it for three years.

Two months ago, Guidant recalled that defibrillator, Prizm 2 DR 1861 models manufactured on or before April 16, 2002, along with two others that could malfunction.

The U.S. Food and Drug Administration has received reports of two deaths associated with 42,000 affected devices worldwide. The July 1 update said that about 20,600 of those were still implanted in patients.

The FDA designated it a Class I recall, meaning that a malfunction could cause serious injury or death, but said it "does not necessarily require removal of the defibrillator."

Class II recalls, meaning the flaws could cause temporary or reversible harm, were then issued for several other Guidant defibrillators. In total, about 109,000 defibrillators are included in the warnings.

Last month, the corporation recalled nine pacemaker models that could short-circuit because of leaky seals. According to Guidant, about 28,000 of the 78,000 originally distributed worldwide are still implanted in patients.

The myriad model names and numbers, the variety of flaws and the talk of programming fixes that fizzled have created confusion and irritation.

"Part of the frustration has been ... with the way the information has been released in bits and pieces," Saba said. "It creates a communication problem between us and our patients."

Patients who called when the first problem was revealed might have been told not to worry because their devices were not affected. But two weeks later, doctors had to contact them because Guidant issued another letter saying their devices were now included, Saba said.

At one point, he noted, doctors were told that a problem with one of the devices could be corrected with a software fix. Then they were told the fix made matters worse, and a change-out was the better option. Shortly after that, a programming change was recommended that corrects the problem.

Despite that, at least one of the 22 UPMC patients who are implanted with those models wants a change-out anyway, Saba said.

Guidant's difficulties have drawn attention to the lack of close monitoring of the medical devices. The Heart Rhythm Society, whose members include arrhythmia experts, is planning a meeting next month with FDA officials.

The main purpose is to talk about what notification physicians and patients need and in what time frame, an FDA spokesman said.

"By no means is Guidant the only company that is having this problem with recalls," Saba noted. "We had to deal with the Medtronic recall in February."

That's when the Minneapolis company warned doctors that the batteries in some of its implanted defibrillators were faulty. St. Jude Medical, a St. Paul, Minn., manufacturer, informed doctors in June that thousands of its devices needed a software fix.

Who pays?
Also contentious is the question of who should pay for change-outs of recalled devices. Guidant will replace the units, but procedure expenses and other costs could be borne by insurers and Medicare.

Denise Grabner, spokeswoman for Highmark Inc., the region's dominant health insurer, said that while patients are being evaluated by doctors for defibrillator replacement, it's not clear who ultimately will pay for the care. Regardless of billing issues, patients are being seen promptly.

Highmark is waiting to hear how Medicare plans on handling the situation, Grabner said, but currently the insurer doesn't even know which patients received the recalled devices.

"We're investigating our options at the moment," she said. "We have to determine the impact for us."

Saba said patients were being prioritized for replacement in part based on whether a defibrillator had administered a lifesaving shock in the past or a pacemaker is regularly needed to maintain a healthy heart rhythm.

The change-outs are "going to have to span a few months, at least," he said. So far, no local patients appear to have been harmed by a faulty device.

But Saba remains concerned about the mixed messages patients have received as conflicting information on device flaws has surfaced.

"We don't want our patients to lose faith in us and we don't want them to lose faith in the fact they need a defibrillator," Saba said. "This is what worries us a little bit."