The bill was introduced by Democratic Reps. Frank Pallone Jr. of New Jersey and Henry Waxman of California after a Minnesota federal district court dismissed lawsuits filed against Medtronic by 1,496 individuals harmed by their malfunctioning Medtronic defibrillators.

In 1997, Medtronic suspended the sale of many of its Sprint Fidelis Defibrillator leads after receiving reports of fatalities connected to the devices. The devices were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether.

The patient convergence in Washington, D.C., was accompanied by public service announcements that feature Don Hickey, who was shocked repeatedly by his Medtronic heart device after undergoing surgery. He later found out doctors replaced his defibrillator with the same, defective model. According to the law, he cannot sue the maker of his medical device.

Alternatively, the videoes also feature Diana Levine, who lost her arm from what she calls faulty labeling of a drug by its manufacturer. She successfully sued both her doctor and the drug company. The injustice she sees is that people, like her, who have been harmed by pharmaceutical companies, can seek justice in court, whereas individuals like Hickey who have been harmed by faulty medical devices, cannot.

“If you can’t hold a corporation responsible when a product with FDA approval hurts you, that’s like giving a corporation a license to hit and run,” Levine told The Minnesota Independent. “What’s really crazy is now there are two laws. The Supreme Court has said that people like me who are hurt by bad drugs can sue. But people like Don who are hurt by bad medical devices cannot. It’s time we finish the job. We need to all work together to pass the Medical Device Safety Act.”

SOURCE: Sprint Fidelis Lead Recall › Patients converge on Capital Hill for right to sue Medtronic

In Canada, 2,416 patients had the Medtronic defibrillators implanted as of February 2005, with 613 of them having been removed or replaced as of June 2007.

In 2005, Medtronic announced that it was recalling two heart defibrillators because they had been linked to at least four deaths and one injury. These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmia’s, originating in the lower chambers of the heart.

The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock. Medtronic said that some of the recalled defibrillators failed to charge properly, a defect which can result in the late delivery or no delivery of cardiac shock therapy. Medtronic had actually discovered the problem with its defibrillators in 2003, but did not disclose the problems immediately.

In October, Medtronic agreed to pay $130 million to settle U.S. claims it hid the defects in the defibrillators, $55 million more than it proposed in a July settlement, people familiar with the agreement said at the time. The company agreed to the higher amount after more claims were filed over the heart defibrillators than the parties expected, the people said.

But the October settlement was not the end of Medtronic’s defibrillator woes. That same month, 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.

Just last week, lawyers for Medtronic went before the US Supreme Court to ask that people injured by defective medical devices and drugs should not be allowed to sue manufacturers if those products have been approved by the Food & Drug Administration.

December 10th, 2007 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic dfibrillator cass ation lawsuit gets go ahead in Canada

Doctors checked the hospital’s records and discovered four similar cases had occurred in recent months. Each stemmed from a broken wire — called a lead — that tells a defibrillator when to send an electric shock to a malfunctioning heart. All six cases involved the Sprint Fidelis 6949, manufactured by Medtronic Inc., a leading medical-device maker.

Within days, the Heart Institute concluded that the Sprint Fidelis wasn’t safe enough, told the company of its concerns, and stopped using the product.

Across the country, physicians at leading hospitals from Chicago’s Children’s Memorial Hospital to Boston’s Brigham and Women’s Hospital came across similar problems and some took similar steps.

But it wasn’t until this month that Medtronic of Minneapolis reached the same conclusion. On Oct. 7, Medtronic President and Chief Executive Bill Hawkins convened a meeting of top executives who decided that the company should suspend sales of the Fidelis leads. In one of the biggest recalls of a medical device, it pulled all Sprint Fidelis models from the market, citing five deaths in the devices’ three years on the market.

The events surrounding the Medtronic recall expose a hole in the U.S.’s medical safety system: Medical devices are regulated under different standards from those applied to prescription drugs. The Food and Drug Administration requires that almost all new medications be tested in human trials before they go on the market. But some devices, like the Sprint Fidelis leads, are subject to lighter guidelines because they are considered modifications of earlier products. The FDA, in most cases, also doesn’t mandate major studies of medical devices after they’ve hit the market.

As a result, both the federal agency and the company were handicapped in evaluating whether a widespread public health threat was emerging.

Pieces of Information

Daniel Schultz, director of the FDA’s device center, says that over the last several months, “we had pieces of information that suggested there were certain problems associated with the Fidelis lead.” But, he says, “there was nothing we could point to specifically to say this is a violative product that needs to come off the market.”

Sen. Charles Grassley, an Iowa Republican who has been critical of the FDA, is examining its handling of the Sprint Fidelis leads. The agency, meanwhile, says it is developing a new surveillance program that will help it independently monitor the safety of heart devices.

“Are there ways to identify problems more quickly?” Dr. Schultz asks. “I think the answer is yes.” But, he adds, “if you require a clinical trial for every design change, what does that do to the ability of bringing new technologies to market?”

As the Fidelis leads mystery unfolded, the FDA relied almost solely on Medtronic’s limited data. That left private cardiologists, including those at the Minneapolis Heart Institute, to ring the alarm bells, pressing both Medtronic and the FDA for action.

Throughout 2007 — and as recently as late September — Medtronic sought to reassure doctors, at times blaming the problems largely on physicians’ technique. In March, a Medtronic letter to doctors said its investigation “suggests that variables within the implant procedure may contribute significantly to these fractures.” In announcing that it was suspending sales of the Sprint Fidelis leads on Oct. 15, the company said they were failing at a rate of 2.3% over 30 months, more than twice as often as its other top lead.

Although the difference wasn’t yet statistically significant — that is, it could still have plausibly been due to chance — the safety gap between the two types of wires was widening.

Rob Clark, a Medtronic spokesman, says the company didn’t hide the problems or delay revealing them. He says Medtronic couldn’t rely on data from individual hospitals and needed time to complete its statistical analysis and confirm that there truly was an excessive fracture rate with Sprint Fidelis. “Physicians disagree on the data,” Mr. Clark says. “Some still think this device should stay on the market.”

Defibrillators are life-saving devices that dispatch shocks to treat cardiac arrest and restore normal heart rhythm. To work properly, they depend on leads, the complex wires that connect defibrillators to the heart muscle. The wires sense aberrant heart rhythms and deliver jolts of electricity to revive a dying patient.

Fractured wires can deliver unneeded and frightening shocks — and, on occasion, can cause a lethal heart rhythm. Yet thick-diameter leads have been known to pose risks. So for years, doctors clamored for ever-narrower designs, partly because blood clots tend to form around broader ones.

Medtronic answered their call with the Sprint Fidelis, among the thinnest leads, with a diameter of 2.2 millimeters — about the thickness of a nickel. In late 2004, the device gained FDA approval and it quickly became the world’s most widely used defibrillator lead.

By early this year, about 90% of new Medtronic defibrillators used Fidelis leads. Some 268,000 of the devices have been implanted in people around the world, and about 235,000 remain in patients’ chests. The leads have brought in about $1 billion in revenue for Medtronic, which has annual sales of more than $12 billion.

Like other leads made by Medtronic and its competitors, the Fidelis leads occasionally broke. But the issue went largely unnoticed until those two patients walked into the Minneapolis Heart Institute’s pacemaker and defibrillator clinic, in January.

In both cases, doctors at the clinic determined that the patients’ Fidelis leads had fractured and misfired. It worried Linda Kallinen, the clinic’s technical director. “We wondered if this was happenstance, or not,” she says. Adrian K. Almquist, the doctor who treated the patients, found the cases odd because the fractures had occurred within roughly two years of implant.

Scouring electronic logs of other clinic patients, Ms. Kallinen found reports of four other Fidelis fractures in the previous seven months. She and Dr. Almquist went to Robert G. Hauser, a senior consulting cardiologist at the Heart Institute who has made a career of studying defects in heart devices.

In 2005, Dr. Hauser, 68 years old, was instrumental in triggering the recalls of more than 200,000 defibrillators and pacemakers made by Guidant Corp., now part of Boston Scientific Corp. Eight years ago, he organized other cardiologists to create a private database of failures in defibrillators, pacemakers and leads.

After hearing from Ms. Kallinen and Dr. Almquist, Dr. Hauser combed through his multi-hospital database. He found similar trends of fractures in that database as well as multiple Sprint Fidelis lead failures in a separate federal database. The Heart Institute decided to stop implanting the Fidelis leads altogether and substitute an older Medtronic lead that appeared to be safer, the Sprint Quattro.

Dr. Hauser contacted Medtronic. In February, he and several other clinic physicians met at the Heart Institute with Warren Watson, a Medtronic vice president, and an engineer. Dr. Hauser says he told Mr. Watson that Medtronic had a serious problem with its Fidelis lead. Three identical device defects at one hospital, he argues, can signify a broader problem.

Mr. Watson disagreed that there was enough evidence yet that the Fidelis lead performed worse than others, several participants in the meeting recall. Medtronic officials also suggested that lead fractures could have resulted from doctors’ mishandling the devices, according to participants. “They were blaming the implanters,” says Dr. Almquist, who says he was offended by the suggestion.

Mr. Watson and other Medtronic officials declined to be interviewed for this story. Mr. Clark, the Medtronic spokesman, wouldn’t discuss specifics of the meeting, but said there were hospitals that had implanted hundreds of Fidelis leads with no fractures.

At the same meeting, Medtronic officials shared their own internal analysis of Fidelis leads that had been returned to the company. The data showed that from late 2004 through February of this year, there had been 226 fractures, for a 0.15% failure rate, in the Fidelis. That compared with 64 fractures, or a failure rate of 0.05%, in Medtronic’s other defibrillator lead.

The return-rate data are imperfect, however, because few leads are ever returned to the company. (Doctors often leave faulty leads in bodies and insert new ones because removing leads risks torn veins and dangerous bleeding.)

The FDA uses its discretion to determine whether a manufacturer should perform a safety or surveillance study after a device goes on the market. In the case of Sprint Fidelis leads, an agency spokeswoman said, the FDA didn’t require any such study because “no issues were raised in premarket review that suggested the need for a post-market study.” Since the Fidelis was similar to an earlier design, the FDA hadn’t required pre-marketing testing in human patients, either.

Agency officials also say that engineering bench tests can be more valuable than small human trials which might not identify relatively rare or longer-term problems.

As with all devices, Medtronic has to file reports of Fidelis problems, reported by doctors or others, to the FDA’s safety database.

Monitoring Patients Remotely

Medtronic had begun on its own a study as the leads went on the market. By March it had data on 487 patients. The month before, a team of Medtronic analysts had begun the laborious process of tapping into CareLink, a proprietary system that allows doctors to monitor patients and their defibrillators remotely by phone or computer. Using computer files on 25,000 patients fitted with Fidelis leads, the analysts set out to measure fractures and pre-fracture conditions. They also had to contact doctors and hospitals to verify that what they were assembling matched doctors’ own records.

In part due to information from Dr. Hauser, Medtronic on March 21 sent out a “dear doctor” letter saying, “Medtronic has received reports from a limited number of implanting physicians indicating they have experienced higher than expected” fracture rates. The letter cautioned doctors about how to handle the device to avoid problems.

Meanwhile, Dr. Hauser submitted a manuscript to the journal Heart Rhythm. Based on his analysis of his multihospital database as well as a federal database, Dr. Hauser concluded that “the Sprint Fidelis high-voltage lead appears to be prone to early failure.” He sent an early copy of the manuscript — whose findings would be published by Heart Rhythm online in April — to the FDA and Medtronic.

The manuscript “put Sprint Fidelis on our radar,” says the FDA’s Dr. Schultz. Still, the implications of one bad shock — even one death — in isolation were hard to discern, FDA officials say. The agency lacked details about some incidents. Given the lack of information, it couldn’t put them in context, or be sure they were all tied to a specific pattern of failure.

By this spring, doctors were reaching their own conclusions. Frank Mazzola, an electrophysiologist at Long Island Jewish Medical Center in New Hyde Park, N.Y., stopped using the Sprint Fidelis in April after seeing patients with lead fractures.

Multiple Shocks

Physicians at Brigham and Women’s Hospital did the same after they too saw problems. At Western Pennsylvania Hospital in Pittsburgh, cardiologist Leonard I. Ganz says he stopped using the Fidelis leads in May after two patients suffered multiple shocks. “Even though there was no statistical trend yet, I was concerned enough that it might be” in time, Dr. Ganz says.

Medtronic maintains that many hospitals using Sprint Fidelis implants weren’t experiencing any problems with fractures.

On July 19, Medtronic officials met again with Dr. Hauser and other physicians at the Heart Institute. Dr. Hauser urged Medtronic to stop selling the leads. Medtronic’s vice president for quality and regulatory issues, Reggie Groves, demurred, using a PowerPoint presentation to show that the incidence of fractures still wasn’t statistically significant, according to people present. The company declines to elaborate.

According to the Heart Institute’s Ms. Kallinen, Medtronic’s Ms. Groves said the company had identified a problem and was working on a possible remedy, but had no intention of pulling the leads off the market.

The company was trying to get to the bottom of what was becoming a crisis. Medtronic says it learned about the five deaths potentially linked to Fidelis leads between August 2006 and this September. The patient study it had begun in 2004 by late July had data on 654 patients, and the separate, eight-month CareLink analysis of 25,000 patients was well under way. Using that information, Medtronic analysts by October determined that the Fidelis overall failure rate — 2.3% over 30 months on the market — was higher than the 0.9% rate for one of its Quattro models.

Medtronic consulted its outside advisory committee of heart doctors, who thought the company had to act. Just after midnight on Oct. 15, the company issued a news release saying it was withdrawing all Sprint Fidelis leads from the world-wide market. The release quoted Mr. Hawkins as saying the recall “is the right thing to do given currently available information.”

October 29th, 2007

SOURCE: Sprint Fidelis Lead Recall › Medtronic recall exposes gaps in medical safety

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

SOURCE: Sprint Fidelis Lead Recall › Heart device recall poses a quandary for patients