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Which Guidant cardiac defibrillator was implanted?








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Glitch prompts recall of Boston Sci Defibrillators

Apr 10, 2007 | Pioneer Press

Boston Scientific is recalling about 73,000 implantable cardiac defibrillators because of a problem with some device batteries, but a company official said Tuesday that the issue might affect just a small subset of patients with the devices.

A notice posted Tuesday about the recall by the U.S. Food and Drug Administration also noted, "Most patients will not be affected by this recall."

The devices in question contain a faulty capacitor that can cause batteries to deplete sooner than expected. The problem has resulted in no serious injuries or deaths, the company says, and the early battery depletion issue can safely be handled with increased monitoring by physicians.

ICDs are $30,000 implanted devices that can shock a failing heart back into rhythm. Boston Scientific manufactures implantable defibrillators and pacemakers at a facility in Arden Hills.

The local division was rocked by a series of high-profile product recalls in 2005 and 2006, when Indianapolis-based Guidant Corp. owned it. Doctors said the latest recall, by comparison, raises a minor issue for patients.

"I think this problem is manageable and poses minimum risk for patients provided they have adequate follow-up," said Dr. Robert Hauser, a cardiologist with the Minneapolis Heart Institute. "It is less worrisome than earlier recalls because the battery depletion can be detected and corrective action (replacement) taken before the ICD fails."

While the clinical impact of the latest recall
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seemed small, Tim Nelson, an analyst with Piper Jaffray Cos. in Minneapolis, said he worried that the news would add to the string of negative reports about implantable defibrillators, nonetheless.

"A lot of patients are going to be notified, and there's a potential fear factor that could arise as the media starts to publicize this," Nelson said. "The real impact could be on the length of time it takes for the industry to start growing again."

In a letter sent to physicians April 5, Boston Scientific asked doctors to check the voltage level and age of the potentially affected devices. That process should determine large groups of patients for whom the product advisory does not apply, said Annette Ruzicka, spokeswoman for Boston Scientific's Arden Hills division.

The remaining patients will need to be checked more frequently and, ultimately, could require replacement devices a few months earlier than normal, Ruzicka said.

"We actually have a recommendation for physicians that eliminates patient risk," she said. "Most of the patients who have these devices will never even be affected or need to know about this."

Nonetheless, Boston Scientific also sent letters to patients, notifying them about the battery-depletion problem. The issue has surfaced in 19 devices since the last quarter of 2006, the company says.

"There is a very low likelihood that a component within your defibrillator may cause the battery in your device to use energy faster than expected, which could reduce the amount of time available for replacement," the company wrote in the letter to patients. "No patients have been harmed; however, some devices have required early replacement."

Natick, Mass.-based Boston Scientific purchased Guidant last year. The controversy involving earlier ICD recalls involving the local division dates back to 2005, but continues to depress the market for implantable cardiac defibrillators.

The current recall includes various models of Guidant's Contak Renewal 3 device, as well as five versions of its Vitality ICD product. The recall is unrelated to a May 2006 recall at Guidant that also dealt with a faulty capacitor, according to the FDA notice.

The agency encouraged patients with recalled devices to contact their doctors about what steps to take next.

"In some cases, more frequent device checks may be advised," the FDA said. "Only in rare cases will a device need to be removed prematurely from a patient."


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