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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.
The Food and Drug Administration (FDA) is cracking down on makers of medical devices that fall in the most risky category of products approved by the FDA, ordering the companies to provide tougher evidence of their products’ safety and effectiveness or pay for extensive clinical trials for their products currently on the market, according to the Wall Street Journal.
Ron Albrecht lives in fear – fear that one day he will learn that the defibrillator implanted in his chest is defective and will cause him excruciating pain when it fails, like his previous one did two years ago. That device turned out to be among the defective heart defibrillators that were recalled by the device’s manufacturer, Medtronic. Albrecht’s device had to be replaced, and while his new one appears to be operating fine, he still worries.
Medtronic Inc. has issued a letter to doctors stating that a defective lead wire in its popular heart defibrillator, which was recalled in October 2007, may have contributed to the deaths of 13 individuals in which the heart devices were implanted, according to the Star Tribune. That death toll is up from the medical device company’s original estimate two years ago of five deaths.
Congressional dems seek reversal of Supreme Court DecisionA new study published Monday in the Heart Rhythm medical journal suggests that the more than 200,000 recipients of Medtronic heart defibrillator leads may be at a greater risk than previously thought.
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.
Two area residents have filed federal class-action lawsuits over malfunctions they said could occur in Medtronic Inc. heart defibrillators implanted in more than a quarter-million patients.
In late January, something unsettling happened at the Minneapolis Heart Institute. On two successive days, patients came to the clinic after their heart defibrillators had jolted them with huge, unnecessary and painful electric shocks. One 65-year-old woman said she’d been zapped 14 times in an hour.
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
