A 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.

The leads, known as Sprint Fidelis lead, connect electrical defibrillators to the hearts of patients with aberrant cardiac rhythms and deliver a jolt to the heart as needed to return the heartbeat to a normal rhythm. The devices were recalled by Medtronic two years ago after fractures were spotted in the devices, which caused them to fail. Medtronic says the faulty leads may have contributed to five deaths.

Removing the leads can put patients at serious risk. Medtronic and some health experts have advised that the leads not be removed unless the device showed signs of fracturing. An estimated 150,000 Sprint Fidelis leads remain in patients.

But the latest study, conducted by Dr. Robert G. Hauser of the Minneapolis Heart Institute and Dr. David L. Hayes of the Mayo Clinic, suggest that patients’ risk increases as the devices age. The report has some experts suggesting that, contrary to previous advice, for some patients, removing the Fidelis lead may be appropriate if the benefits outweigh the risks.

The study is based on data from 3,000 patients who had any brand of defibrillator leads implanted at the Minneapolis Heart Institute or the Mayo Clinic between 2004 and 2008. Twenty-eight percent of the leads were the Sprint Fidelis brand. The data showed that 3.75 percent of the Sprint Fidelis leads failed compared to 0.6 percent for other leads. The data also showed the failure rate was increasing.

Medtronic stands on its own data, issuing a statement: “It is important to note that data collected from center to center would be expected to vary. We believe that our analyses are representative of overall Fidelis performance.”

According to the New York Times, Congressional Democrats plan to reintroduce legislation that would nullify a Supreme Court decision last month to dismiss lawsuits against Medtronic for the defective leads, citing a ruling last year that shielded makers of certain medical devices from product liability lawsuits.

SOURCE: Sprint Fidelis Lead Recall › Study shows heart leads may fail as they age

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. 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. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

Since it was put on the market in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests. But in spite of such widespread use, the FDA never required the Sprint Fidelis Leads to be tested in humans before they were marketed, and it did not monitor the device after it was introduced.

Within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. The problems were disturbing enough that the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country.

The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

Despite being informed of the Minneapolis Heart Institute’s Sprint Fidelis Lead study, the FDA did nothing. An FDA spokesperson told the Wall Street Journal in October that the agency did not require any post-market surveillance of the Sprint Fidelis Lead because “no issues were raised in the premarket review that suggested the need for a postmarket study.” It wasn’t until 5 patients died that the defective Medtronic Sprint Fidelis Lead was removed from the market.

Because of the FDA’s poor oversight of implantable medical devices, thousands of people with Medtronic Sprint Fidelis Defibrillator Leads must live with the knowledge that the defective component could fail at anytime. In general, this poor FDA oversight means that patients with any type of implantable medical device can’t be sure that they don’t face similar dangers.

January 2nd, 2008 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Poor FDA scrutiny of Medtronic Sprint Fidelis lead

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. 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.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it was one of the thinnest defibrillator lead wires on the market. Prior to the recall, Sprint Fidelis Leads had been implanted with 90% of Medtronic’s defibrillators since being introduced in 2004. According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests.

Within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. The problems were disturbing enough that the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country. The researchers found that the thinner Sprint Fidelis Lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis Lead, and the study authors informed the Food & Drug Administration (FDA) that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor.

While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

But even as it sent out that letter, Medtronic was gathering evidence that the Sprint Fidelis Lead was more prone to fracturing than the Sprint Quattro. According to the Wall Street Journal, data collected by Medtronic revealed that from late 2004 through February 2007, there had been more than 200 fractures reported for Sprint Fidelis Leads. That was compared to 64 for Medtronic’s Sprint Quattro Leads.

Then, sometime between August and September of this year, Medtronic said it learned of 5 deaths linked to Sprint Fidelis Lead fractures. And by October, the Medtronic analysis had revealed that the defective Sprint Fidelis Leads had a 2.3% fracture rate within 30 months of implantation. Those grim statistics where finally enough to persuade Medtronic to recall the defective Sprint Fidelis Defibrillator Lead.

The Sprint Fidelis Defibrillator Lead recall sent Medtronic scrambling to get more Sprint Quattro models onto the market. Despite that, the company says it won’t have any trouble meeting the demand for Sprint Quattro Leads. In light of the recall, it looks as though there was never any need for Medtronic to replace the more reliable Sprint Quattro Defibrillator Leads.

November 23rd, 2007

SOURCE: Sprint Fidelis Lead Recall › Sprint Fidelis defibrillator lead wire recall

At the time of the recall, Medtronic took great pains to underscore that the Fidelis leads had a 2.3 percent failure rate after 30 months of implantation. That compared to a 1 percent failure rate among the company’s Quattro leads, which have been around longer and are wider in diameter.

On a conference call with analysts Monday, Medtronic’s president of Cardiac Rhythm Disease Management, Pat Mackin, said the company erred on the side of caution by pulling the Fidelis lead.
“We made a very conservative call with this lead. There is no statistically significant difference between Fidelis and Quattro, but we figured it would become so over time, which is why we made the action we did,” said Mackin.

“We have a rule of thumb, and that is if you see three of the same thing at one center, you’d better pay attention to it, because it’s likely not due to chance,” said Dr. Robert Hauser, a cardiologist at the Minneapolis Heart Institute.

Hauser’s clinic stopped using Medtronic’s Fidelis lead in January after tracking six incidences of injuries from it.

In March, Hauser and his colleagues submitted an article about the problems they saw to the journal Heart Rhythm. That same month, Medtronic issued a letter to patients and doctors advising them of concerns about the Fidelis lead.

Hauser says Medtronic was actually very cooperative in addressing his worries about the product. And he believes Medtronic’s claim that the company had to collect more data before it made sense to pull the leads from distribution.

But Hauser takes a less generous view of how the Food and Drug Administration handled things.
“When Medtronic sent a letter to physicians stating they ‘may’ have a problem, from that point on, in my view, the ball was in the FDA’s court,” Hauser says. “In retrospect, what might’ve been done was for the FDA to say simply, ‘Look, if you think you have a problem, why don’t you stop implanting until you figure out what the problem is.’”

Sid Wolf of the watchdog group Public Citizen thinks both the FDA and Medtronic moved too slowly. He says that their responses remind him of Guidant’s device problems in 2005.

Minneapolis Heart Institute doctors, including Hauser, had alerted Guidant to device failures, and the doctors later accused the company of refusing to acknowledge the problems publicly.

Wolf sees a similarity in the events prompting Fidelis leads to be taken off the market.

“When I saw the announcement that this was being taken off, and the horrible self-congratulatory statements that were being made both by the FDA and Medtronic, ‘We’ve done a much better job here than we’d done with Guidant,’ I said to myself, I doubt that that’s the case. And the more that one looks into this, it starts smelling like the Guidant thing,” says Wolf.

But both the FDA and Medtronic say it’s not realistic to pull thousands of products from the marketplace with limited data.

Medtronic spokesman Rob Clark says the company did hear reports from such individuals that had stopped using the Fidelis leads, because they had seen a number of injuries.

But Clark says Medtronic also looked at other medical centers, which had done hundreds of Fidelis lead implantations without a hitch. The overall picture wasn’t clear.

“Often when a design issue or a manufacturing issue is associated with a product, you will see that playing out across all centers, and not just pockets of centers,” Clark says.

That’s an assessment with which a number of experts agree. Dr. William Maisell is director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center. He says what was important for Medtronic to ascertain was not the number of failures on its hands, but the rate of failures.

Maisel favored a recall for the Medtronic leads. But in some ways, he thinks letting patients and doctors make informed choices about using the product is even more important than the recall itself. He gives this example.

“With the Fidelis, the fracture rate is 2.3 percent, but it’s also one of the smallest and thinnest leads on the market,” says Maisel. “So I can imagine a clinical situation where I might be willing to accept a higher fracture rate on a lead in exchange for its very thin and small, size, if I had a patient or a vessel that was very thin, and that was the only lead I could fit down there.”

Daniel Schultz, the director of the FDA’s device center, says in the end, a lot of factors have to be considered in any recall. He says in the Medtronic case, the dramatic tipping point was hard to find.

“It’s not always black and white, where you get to a line and say ‘Aha, it’s clear, it’s crystal clear,’” says Schultz. “Many times it’s going from white through this gray zone, of weighing the various consequences and deciding when to make the decision.”

Schultz says one way to make that decision easier going forward is for companies like Medtronic to gather better data on leads implanted in patients, so that problems can be identified at an earlier stage.

Some observers say that’s something the FDA itself should mandate. Schultz gave no indication that’s likely.

November 19th, 2007

SOURCE: Sprint Fidelis Lead Recall › Did Medtronic act quickly enough on recall

Back in March, Medtronic sent letters to doctors warning them about the risk of fractures in leads and reminding doctors of the proper way to use the leads. By this point, some doctors had already realized that the Sprint Fidelis leads were prone to fracture. However, patients were not made aware of the problem until March, when Medtronic recalled the leads. Many patients are now concerned that they have defective leads that may fracture, causing them to experience serious, unnecessary shocks or causing their defibrillator to not administer a necessary shock.

Meanwhile, a shareholder who alleges that the company concealed information about defective lead wires has also filed a lawsuit. The suit seeks unspecified damages from Medtronic and claims that Medtronic’s actions constitute securities fraud.

According to the lawsuit, since October 15, the day that sales of Sprint Fidelis leads were suspended, shares in Medtronic have dropped from $56.33 to $45.99. At the time, Medtronic reported that at least five confirmed deaths have been linked to defective lead wires. The lawsuit seeks class action status on behalf of those who bought Medtronic stock between June 25, 2007 and October 15, 2007, the period during which Medtronic allegedly made false and misleading statements. Among the statements was a claim in a securities filing that the Sprint Fidelis leads had a “strong market acceptance,” and a claim that there was increasing clinical data to support the use of Sprint Fidelis leads.

However, by January 2007, Medtronic allegedly already had 679 reports of injuries caused by defective leads. According to the lawsuit that number grew to 795 by April 30, 2007 and then jumped to 1,053 injuries reported two months later. Furthermore, Medtronic learned in February 2007 that the Minneapolis Heart Institute would stop using Spring Fidelis leads in its surgeries and replace them with the Sprint Quattro leads.

Medtronic has estimated that the failure rate for its leads is around 2.3 percent. That is just over two times the failure rate of the company’s other leads. However, the risk of serious complications associated with replacing the leads can be as high as seven percent. Replacing the Sprint Fidelis leads can cause damage to the veins that the leads run through.

Patients who have recalled Sprint Fidelis leads implanted are understandably concerned that their leads could fracture and fail at any time, putting their lives at risk. Those who have already had their leads fail report that the unnecessary shocks are incredibly painful.

November 15th, 2007

SOURCE: Sprint Fidelis Lead Recall › Medtronic Sprint Fidelis leads facing more lawsuits

The 54-year-old Minneapolis woman has stared down a rare breed of late-stage cancer. And last year, she technically died after her heart stopped beating, but luckily her near-fatal attack occurred just outside Fairview Southdale Hospital in Edina.

She left the hospital with an implantable cardioverter defibrillator (ICD) made by Medtronic Inc. tucked inside her chest, a kind of medical-device insurance policy intended to shock her heart back into rhythm if she goes into sudden cardiac arrest.

“I have faced the darkest day,” she said recently.

But on Oct. 15, Lewis learned that Fridley-based Medtronic had pulled a key component of her defibrillator system, called a lead, off the market because it may fracture in the body. A lead is an insulated wire that connects the stopwatch-size portion of the device containing the battery to the heart.

“After all that I’ve been through, I just didn’t think it was going to be me,” she said.

Like many of the 235,000 patients worldwide implanted with Medtronic’s Sprint Fidelis lead, Lewis immediately called her doctor for an appointment.

She, and many others, have embarked on a series of phone calls to doctors and insurers that may prove confusing and frustrating.

All face similar options: Remove the leads — an often difficult surgery — and replace it with a new one. Leave the old lead in the body and snake a new one in the chest using a different vein. Or reprogram the defibrillator to new settings that may detect fractures.

That option would leave the leads in place, and they would have to be frequently tracked using sophisticated monitoring equipment.

Medtronic and the U.S. Food and Drug Administration (FDA) have advised patients to leave the leads intact. But for many patients, the choice isn’t so clear-cut. The potential rate of fracture is small, at 2.3 percent, but a risk nonetheless.

Lewis, a computer science graduate student at the University of Minnesota, didn’t like the odds of potential failure for her Medtronic lead. Plus, she already had experienced odd shocking sensations across her chest on several occasions before the lead recall, a possible indication that it may be defective.

When she asked her doctor at Fairview Southdale about having the lead removed, she was told that the Mayo Clinic was better equipped for the procedure, but that extracting it was considered an “elective” procedure, which meant she would have to pay for it.

Some major health plans in the state — including Medica, HealthPartners and Blue Cross Blue Shield of Minnesota — say they will cover the cost of replacing the Sprint Fidelis leads if that’s what the doctors order. Medtronic says that it will provide new leads free and cover as much as $800 in non-reimbursed medical expenses — but only if a lead is fractured. The device’s warranty doesn’t cover prophylactic removal, according to a company spokesman.

A few days after Lewis’ initial doctor’s visit, a scheduler from Mayo called to set up an appointment. “We’re not going to recommend that you replace it,” Lewis says she was told. Lewis couldn’t believe her ears — she hadn’t even seen the Mayo doctor yet.

The experience has left Lewis feeling whipsawed. “At this point, I just want them to turn this thing off,” she said.

The advocate

After the news broke on the Sprint Fidelis lead, Lisa Salberg sprang into action. As a defibrillator patient and founder of the Hypertrophic Cardiomyopathy (HCM) Association, Salberg is pressing for stepped-up surveillance of lead performance that is funded and conducted independently of the medical device industry. (Companies track the performances of their own devices.)

She presented her ideas this month to high-powered cardiologists at a major clinical meeting in Florida. She’s working with Dr. Robert Hauser of the Minneapolis Heart Institute Foundation — a whistleblower in the recall of Guidant Corp. defibrillators two years ago, and a diligent tracker of heart device performance — to set up a system that could spot potential problems in devices such as the Fidelis lead early on.

But Salberg, of Rockaway Township, N.J., is personally affected by the Sprint Fidelis news, too. Her 12-year-old daughter and 72-year-old father have HCM, a genetic heart condition — and both have implanted Sprint Fidelis leads.

“It was really hard to sit my 12-year-old down and tell her that she’s been recalled,” Salberg said. “But she took it really well.” If a lead is failing it will often make a beeping sound to alert the patient. This provided some angst for Salberg’s daughter, a middle-schooler.

“Will my ICD beep in the hallway at school?” she asked her mom.

For now, doctors will monitor Salberg’s daughter’s and father’s leads, but the watching and waiting is difficult, at best.

The fixer

Dr. Pierce Vatterott, a cardiac electrophysiologist with the St. Paul Heart Clinic, wasn’t terribly surprised to hear the Sprint Fidelis news.

In March, Medtronic sent a letter to doctors alerting them to the fracture problem, and reinforcing the proper way to use the devices. Vatterott and his colleagues had noticed a tendency of Sprint Fidelis leads to fracture well before the company stopped selling them.

The gregarious Vatterott is known in Minnesota — and beyond — as an expert in lead extraction. The most difficult and tricky cases often land on his and his colleagues’ desks.

Leads are sometimes hard to remove from the body because scar tissue tends to form over them. Doctors often use a special laser to take them out.

In a procedure that took nearly five hours at United Hospital in St. Paul last week, Vatterott extracted two (non-Fidelis) leads from a 59-year-old man and inserted two more, as well as a new pacemaker. Despite the difficulty and duration of the procedure, Vatterott was elated. “I’m pumped for this patient. He’s going to feel so much better,” he said.

“The Fidelis is relatively easy to take out,” Vatterott said. While the lead is thinner than most others on the market, it’s not as robust, he added. And, if it’s used on younger, more active, patients — which is often the case — more stress is put on the lead, occasionally causing it to fracture.

After the Medtronic news broke, patients and physicians began calling Vatterott’s office. So far, he’s extracted one Fidelis lead from a patient who requested that it be removed.

The recall news “scares patients,” he said. “It’s an unknown. They don’t know what it means.”

While a potentially faulty device is always alarming, Vatterott relishes the challenge of his unique specialty. “You have to be creative on the spot in these procedures,” he said. “You never know what will happen next.”

November 10th, 2007

SOURCE: Sprint Fidelis Lead Recall › A patient an advocate a fixer

Medtronic even went so far as to blame physicians for the problems, claiming that they weren’t implanting the defective Sprint Fidelis Lead properly. What’s even worse, the Food & Drug Administration (FDA), which never required the defective medical device to undergo clinical testing, was oblivious to the increasing reports of Sprint Fidelis Lead problems.

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. 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.

Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

The Sprint Fidelis Lead was designed to replace Medtronic’s Sprint Quattro models, and it is one of the thinnest defibrillator lead wires on the market. Since it was put on the market in 2004, Sprint Fidelis Leads have been implanted with 90% of Medtronic’s defibrillators.

According to the Wall Street Journal, 268,000 defective Sprint Fidelis Leads have been implanted worldwide, and about 235,000 people still have these leads in their chests. But in spite of such widespread use, the FDA never required the Sprint Fidelis Leads to be tested in humans before they were marketed, and it did not monitor the device after it was introduced. The FDA considered the Sprint Fidelis Lead to be a modification over the earlier Sprint Quattro, so it only required Medtronic to conduct limited laboratory testing prior to its introduction.

Within a couple of years of the Sprint Fidelis Lead’s introduction, emergency rooms around the country began to see patients injured by the fractured device. The problems were disturbing enough that the Minneapolis Heart Institute decided to conduct a data analysis of Sprint Fidelis Lead fracture reports from hospital databases around the country.

The researchers found that the thinner Sprint Fidelis lead had a higher chance of fracturing than the Sprint Quattro. As a result of those findings, the Minneapolis Heart Institute quit using the Sprint Fidelis lead, and the study authors informed the FDA that the defective Sprint Fidelis Lead was “significantly less reliable” than its predecessor. While Medtronic did write a letter to doctors in March 2007 warning them of the Sprint Fidelis lead’s possible problems, the company maintained that the fractures were partly the result of the components not being properly implanted.

Despite being informed of the Minneapolis Heart Institute’s Sprint Fidelis Lead study, the FDA did nothing. Medtronic had concluded that the number of Sprint Fidelis Lead fractures were not “statistically significant” and blamed most of them on surgical errors.

An FDA spokesperson told the Wall Street Journal that the agency did not require any post-market surveillance of the Sprint Fidelis Lead because “no issues were raised in the premarket review that suggested the need for a post market study.” But of course, the FDA had not required a premarket clinical trial of the Sprint Fidelis Lead. Because of this, patients and their doctors had no way of knowing that the Sprint Fidelis Lead implanted with a Medtronic defibrillator could be a dangerous ticking time bomb.

But Medtronic knew. It had started a study of the Sprint Fidelis Lead even before it went on the market. According to the Wall Street Journal, that study revealed that from late 2004 through February 2007, there had been more than 200 fractures reported for Sprint Fidelis Leads. That was compared to 64 for Medtronic’s other defibrillator leads. But sources have told the Wall Street Journal that at a July 19 internal meeting to discuss the problem, Medtronic’s management still insisted that the number of Sprint Fidelis Lead fractures was not “statistically significant”.

Then, sometime between August and September of this year, Medtronic said it learned of 5 deaths linked to Sprint Fidelis Lead fractures. And by October, the Medtronic analysis had revealed that the defective Sprint Fidelis Leads had a 2.3% fracture rate within 30 months of implantation.

Finally, unable to deny that such numbers were not “statistically significant,” Medtronic recalled its defective Sprint Fidelis Leads. But thousand of people have been implanted with these leads, and now they must live with the knowledge that their Sprint Fidelis Lead could fracture at any time, placing them in mortal danger. Why the defective Sprint Fidelis lead was not removed from the market earlier, is a question that Medtronic is going to have to answer.

October 31st, 2007

SOURCE: Sprint Fidelis Lead Recall › Defective Medtronic Sprint Fidelis lead fracture reports ignored by company

The leads were implanted into hundreds of thousands of patients who are now at risk of serious injury if their Sprint Fidelis Lead malfunctions. All unused leads were recalled by Medtronic on October 15, although Medtronic is actually referring to the recall as a “voluntary market suspension.” Leads that have been suspended contain the model numbers 6930, 6931, 6948 and 6949 either by themselves or at the beginning of a longer model number. Patients who have defibrillators manufactured by Guidant and St. Jude may also have the Medtronic Sprint Fidelis Lead implanted in them and should consult their physicians to discuss their options.

Sprint Fidelis Leads that have already been implanted are not being removed because surgery to remove a fractured lead wire is risky and can cause tearing or scarring of the heart tissue and veins that house the lead. There is currently no test to predict whether or not a lead will fracture and malfunction, meaning that patients have no way of knowing whether their lead could stop working in the future.

Lawsuits have been filed against Medtronic alleging the company is responsible for causing injury to defibrillator patients. A class action lawsuit was filed on October 15 in Minnesota, seeking compensatory, injunctive, equitable and declaratory relief. The plaintiffs claim that Medtronic misrepresented and concealed the safety and possible defects of its Sprint Fidelis Leads in order to protect profits. The suit also seeks relief for unjust enrichment and medical monitoring.

According to a letter from Dr. Sidney M. Wolfe of Public Citizen to the US Food and Drug Administration (FDA), more than 1,600 injury reports were filed over the past two years, with more than 750 reports listing “inappropriate shocks” as being received by the patient. One of the patients in the Minnesota lawsuit alleges he received 47 unnecessary shocks from his defibrillator because of the faulty wires, resulting in surgery to remove the defective lead.

The letter also notes that the Minneapolis Heart Institute contacted Medtronic in February 2007 about problems related to malfunctioning leads. An article by researchers at the Minneapolis Heart Institute compared lead failures in Medtronic’s Sprint Fidelis and Sprint Quattro models. The study found that the Sprint Fidelis Lead had a higher risk of fracturing than the Sprint Quattro. In fact the Heart Institute was so concerned about defective lead wires that it stopped implanting them in January 2007.

The Sprint Fidelis Lead is actually a wire that attaches the Medtronic defibrillator to a patient’s heart. It works by administering a corrective electric impulse to the heart in patients who have abnormal heart rhythms. However, the leads are prone to fracturing which can cause them to malfunction, resulting in them not delivering a shock when necessary or delivering a series of painful shocks when not necessary. Either situation can be fatal.

There is some concern that young adults and children are at a greater risk of lead fracture because the Sprint Fidelis leads are a smaller diameter than other products and were used frequently in younger patients. Patients who are more active may put additional stress on the Fidelis leads.

If you are concerned that you have been implanted with a Sprint Fidelis Lead, check your patient card that identifies which implanted devices you have. If you do not have a patient card, or are still uncertain as to what devices were used, contact your doctor for more information.

October 30th, 2007

SOURCE: Sprint Fidelis Lead Recall › Patients concerned about Medtronic Sprint Fidelis leads

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