ORLANDO, Fla. – Tom Kern had a potentially lifesaving heart device implanted in his body last year. Now he wonders if it might harm him instead.

The Florida man is caught in the worldwide recall of components used since 2004 in a leading brand of defibrillators, which shock the heart to restore a normal rhythm.

The manufacturer, Medtronic, is warning patients that the wires connecting their hearts to the defibrillators may break. If that happens, the device could not fire if needed. In some cases, it may deliver unneeded shocks to patients.

Medtronic estimates a failure rate of 2.3 percent. With 235,000 of the wires implanted globally, that translates to about 5,000 patients in jeopardy. The Food and Drug Administration is investigating five U.S. deaths that may be linked to the problem.

Kern, 75, feels as if he is carrying a “ticking bomb” in his chest. His dilemma could become more common as the number of implantable devices grows. Already patients can have electrodes embedded in their brains to treat Parkinson’s disease and tiny metal coils placed in heart arteries to prop them open. There are spinal-cord stimulators to soothe pain and pacemakers to keep the heart beating in time.

A medical-device recall is a particularly angst-ridden experience. But physicians say people need to be prepared for the possibility. They should maintain records on their devices, see their doctors as recommended for follow-up and read any mail that arrives from the manufacturer.

“There’s no mechanical device in the world, whether it’s a medical device or nonmedical, that’s not subject to premature failures or problems,” said Dr. Scott Pollak, a Florida Hospital cardiologist who uses the Medtronic system.

In the current Medtronic recall, doctors say most patients are better off leaving the wires in place. The specific components are called the Sprint Fidelis lead.

Because of the potential for infections and bleeding, doctors say the operation to dismantle the wiring system is riskier than the small chance of failure. Medtronic is urging patients to consult their cardiologists, who can make adjustments so that the devices will beep if the wires fracture.

The physicians also can use equipment in their offices to check the health of the system, said Rob Clark, a spokesman for the Minneapolis-based company. He could not say how many wires had been replaced in patients to date. When action is recommended by a physician, Medtronic is paying for the replacement parts and up to $800 in uninsured expenses.

Local cardiologists say they have changed the wiring system in a small number of patients. The suspect wires aren’t actually removed from the body but disconnected from the defibrillator. New wires are then strung to the device.

Most often, doctors are informing people of the potential dangers and monitoring them. Pollak said the situation is frustrating because “there is no perfect solution” to the problem.

“There is not a single one-size-fits-all answer for patients,” Pollak said. “We have to evaluate each case on an individual basis.”

A group of patients who may be better off with replacements are those who use the devices as both a pacemaker and a defibrillator, said Dr. Aurelio Duran, chairman of cardiology for Orlando Regional Medical Center.

He has sent letters describing the problem to about 100 of his patients who have the Sprint Fidelis system. He said people need to maintain good communication with their doctors when they have any implanted device.

“These devices are highly scrutinized (before they go to market), but they are made by human beings, and there is always a small chance that something could go wrong,” he said.


One consumers’ group is not satisfied with the way Medtronic and the FDA have handled the wiring problem. Public Citizen says the defect was evident long before the manufacturer issued its voluntary recall in October.

In a letter to the FDA, the group says a Minneapolis doctor warned Medtronic about a growing number of injury reports as far back as February. The FDA and the company were aware of 599 injuries by January, including 204 reports of “inappropriate shocks,” according to Public Citizen.

Dr. Sidney Wolfe, director of Public Citizen’s health-research group, said the government needs to be more vigilant with products placed inside hundreds of thousands of people.

“The FDA has generally done a miserable job of regulating medical devices, and this is just another example,” Wolfe said.

An FDA spokeswoman said the agency acted as soon as there was sufficient evidence to signal a problem. The FDA looked into the injury reports after hearing from the Minneapolis physician but deemed the data “too spotty to detect a trend at that time,” spokeswoman Karen Riley said.

She said the tipping point came in September, when three events occurred “in close proximity.” They included a death, a serious injury and concerns raised by British regulators.

“We take our responsibilities very seriously,” Riley explained in an e-mail response to questions. “One of those responsibilities is being reasonably sure that safety signals are real before notifying the public. It would be irresponsible to scare patients … if we weren’t convinced there is a real problem.”


Doctors say people who run the risk of abnormal heart rhythms should not hesitate to have defibrillators implanted. About 300,000 Americans die every year when their hearts stop beating altogether, according to the American Heart Association. Defibrillators can provide a lifesaving jolt.

Kern has suffered from heart disease for many years and underwent quadruple-bypass surgery in 1991. He’s had several minor heart attacks since then.

Kern wants the protection of a defibrillator, but the recall experience has rattled his confidence. He plans to evaluate his options with his doctor.

“I try not to let it get to me, but it worries the heck out of me,” Kern said.

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(c) 2008, The Orlando Sentinel (Fla.).

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Distributed by McClatchy-Tribune Information Services.

AP-NY-01-04-08 0610EST

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