Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Another heart defibrillator has fallen under a Class I recall by the Food and Drug Administration (FDA). The recall on ZOLL AED Plus Defibrillators was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest.

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Medtronic Inc., the maker of the faulty Sprint Fidelis Defibrillator Lead Wire, is now facing a lawsuit filed by a group of Canadians who claim the company failed to warn consumers of a defect in the batteries installed in its defibrillators. Last week, Ontario Superior Court Judge Alexandra Hoy certified the class-action lawsuit in a ruling released Dec. 6 in Toronto, allowing the plaintiffs to seek a portion of Medtronic profits for damages.

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Medtronic, Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, is the now the subject of two separate investigations. A Senate panel wants information about Medtronic’s October Sprint Fidelis Defibrillator Lead recall, while a second investigation by the US Justice Department is looking into allegations that Medtronic made illegal payments to foreign physicians.
Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

Following the recall, it was learned that Medtronic had been receiving reports that indicated the Sprint Fidelis Lead had a higher-than-normal fracture rate for months. The incident has raised questions about the Food & Drug Administration’s (FDA) regulation of medical devices, and of the Medtronic’s response to early reports of lead problems.

Medtronic has acknowledged in a Securities and Exchange Commission (SEC) filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic’s suspended distribution of its Sprint Fidelis family of defibrillation leads. The Senate panel is probing the FDA’s oversight of medical-device components.

Medtronic said in the same SEC filing that it is the subject of a Justice Department probe into illegal physician payments. The U.S. attorney’s office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician’s groups related to the purchase of the company’s cardiac stents and cardiac-therapy devices.

The U.S. attorney also asked Medtronic to provide documents related to its relationship with a specific customer. The customer wasn’t identified in the SEC filing. In September, the SEC began an informal probe of Medtronic, seeking information about possible violations of the Corrupt Foreign Practices Act, which is meant to stop bribes to foreign officials.

This is not the first time Medtronic’s relationships with physicians has come under scrutiny. Earlier this year, Sen. Charles Grassley, R-Iowa, requested information from Medtronic about the company’s payments to orthopedic surgeons, and questioned whether they improperly influenced physician decisions about which products to use.

Monetary agreements with physician consultants are common in the medical device industry, where doctors are paid for their work developing products and then, in some cases, for helping to train other doctors in how to use the products. Medtronic insists that it only provides physicians with compensation that is fair, relative to current market values, and is compliant with the law.

December 6th, 2007 by Staff with NewsInferno.com

On Sunday when Medtronic warned physicians to stop using a potentially faulty wire attached to its heart defibrillators, the company also advised patients to consult their doctors. On Monday, anxious patients were doing just that, causing some doctors’ offices to be flooded with calls as people tried to determine whether they might have the defective models.

The risk of a defective wire is low. Medtronic said that about 2.3 percent of the estimated 235,000 patients with the defective wire, or 4,000 to 5,000 people, would experience a lead fracture within 30 months of implantation. But learning through tests that one’s defibrillator has a faulty lead can create agonizing decisions for patients and doctors.

One decision is whether to remove the wire, a procedure that carries some risks, or leave it in place alongside a replacement.

Removal carries significant risk of damage to the heart and veins through which the wire wends from the defibrillator, a generator implanted under the skin near the collarbone.

When working properly, defibrillators deliver a potentially life-saving shock if the heart beats rapidly and purposelessly in a rhythm known as ventricular fibrillation. A surge from the device can restore a life-supporting heart rhythm.

If the Medtronic lead, called the Sprint Fidelis, were faulty, it could simply signal the patient to check with a doctor about a possible malfunction. Or it could deliver a painful, body-rocking shock when such a jolt is not needed. Or the device could fail to deliver a life-saving shock when it is needed.

The malfunction does not involve conventional pacemakers without defibrillators, Medtronic said.

Dr. David R. Broudy, a cardiologist and electrophysiologist who implants defibrillators in Seattle, said Monday that he was in the habit of telling all patients about potential complications when he implants defibrillators. He said there was a 2 to 3 percent chance of complications, including serious infections and malfunctions in leads and other parts.

He says he has 92 defibrillator patients who have a Sprint Fidelis lead, although on Monday he received calls from only three of them. Like other doctors, he said he would send letters alerting patients who do not call.

Medtronic also said that it would send letters to all Sprint Fidelis patients.

Defibrillator patients generally carry cards that contain the lead’s identifying numbers, which in the Medtronic recall are 6930, 6931, 6948 and 6949. Each patient is being asked to come in for computerized testing that could detect abnormalities in resistance and other electrical functions that could signal an impending fracture in the lead.

In Seattle, Dr. Broudy said that in trying to assess what to do for each of his patients with the potentially defective lead, he would check factors like the number of times the device had appropriately delivered shocks and the degree of a patient’s anxiety.

“There are different needs for different patients,” he said. Those who have had frequent abnormal heart rhythms, he said, may be more dependent on the device than others. Even patients in whom no evidence of possible cracks in the leads is found will need to have their Medtronic defibrillators reprogrammed.

The quandary will be for those found to have a fractured lead.

Doctors can insert a new lead into the vein if there is room for it, attach it to the heart, and then put a cap on the old one.

The risks of surgically removing the lead depend in part on how long it has been in place. Scar tissue forms around the lead after it is implanted. Removal can produce bleeding from torn veins and damage heart muscle. The risk of such complications ranges from 1.4 percent to 7.3 percent.

Dr. John Kassotis, director of cardiac electrophysiology at the State University of New York Downstate Medical Center in Brooklyn, said, “You can definitely take the leads out if they have been in less than six months and usually if it is less than two years.”

Patients who do need surgical removal of the lead should go to doctors and medical centers that have extensive experience in performing such procedures, experts interviewed Monday said.

October 23rd, 2007