The Class I recall involves nearly 37,000 of Medtronic’s Sigma and Kappa pacemakers, most manufactured between November 2000 and November 2002. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that the device will cause serious adverse injury or death.

An estimated 15,200 active Kappa devices and 6,100 active Sigma devices are affected by the recall. Many of the devices have been implanted in patients for five years or longer and may be nearing what Medtronic calls normal elective replacement time. Of the active Kappa and Sigma devices, Medtronic has observed 285 Kappa devices and 131 Sigma devices with the failure mechanism.

Patients with a malfunctioning pacemaker may experience a return of symptoms associated with abnormal heart rate such as fainting or lightheadedness. In rare cases, pacemaker-dependent patients may experience serious injury or even death, according to the FDA’s recall notice. Patients with questions about their pacemaker should contact their primary care physician or cardiologist, who can help identify if the patient’s medical device is included in the recall.

Source: FDA

SOURCE: Sprint Fidelis Lead Recall › FDA issues Class I recall for faulty pacemakers

According to an internal FDA document, senior officials with the agency’s Center for Devices and Radiological Health (CDRH), which is charged with overseeing the safety of medical devices, made a decision to ignore the Good Laboratory Practice (GLP) regulation and as a result put patients’ lives at risk.

The controversy stems from a new classification of medical devices that resulted from a federal loophole that allowed products that are “substantially equivalent” to combinations of other products marketed before 1976 to be sold. As a result, hundreds of new “Class C” devices were approved and made available for use.

Class C is the FDA’s most risky category and includes heart defibrillators from Medtronic Inc. In 2007, Medtronic suspended the sale of its Sprint Fidelis Defibrillator leads that are used on Medtronic implantable defibrillators, after reports of deaths and injuries to patients with the defibrillators with leads that had fractured or broken causing the defibrillators to shock inappropriately or not at all.

The debate will continue in Congress with the June 18th hearing.

SOURCE: Sprint Fidelis Lead Recall › Congressional hearings continue on Medical Device Safety Act

Mikulski asked Dr. Hamburg if she would heed concerns made by whistleblowers, such as those made by a group of employees at the Center for Devices and Radiological Health that in January accused the FDA of carelessly approving medical devices which ultimately put patients’ health and safety at risk.

Dr. Hamburg replied that she would see to it that critical issues and concerns raised by whistleblowers would be addressed by the agency if she is confirmed as commissioner.

The scientists allege that the FDA had approved medical devices for sale even after their review of many medical devices had resulted in serious objections by the scientific team reviewing them. One device approved under such circumstances included Medtronic cardiac defibrillators. It was later found that many of the defibrillators had defective leads that had caused the defibrillators to unnecessarily shock patients or fail to work all together. According to a Supreme Court ruling last year, because the devices had been approved by the FDA, those injured by the faulty devices were unable to sue the manufacturer.

As a result, a large collation of consumer and patient safety groups teamed up to push the Medical Device Safety Act (MDSA), legislation that would restore the rights of patients who have been harmed by unsafe medical devices to seek justice in state courts.

SOURCE: Sprint Fidelis Lead Recall › Hamburg hopes to create a culture in FDA where concerns are heard

The meeting, which includes all scientists within the medical device evaluation office, is a rare gathering and likely to establish a plan for how the agency will handle a slurry of controversial issues including a Congress-initiated investigation of the device division by the Institute of Medicine, according to the New York Times.

The investigation is spurred by allegations from nine scientists who have separated themselves from the FDA, who have signed letters to President Obama charging that agency officials approved medical devices for sale despite often unanimous objections from scientific reviewers.

AAJ has been working with a large coalition of consumer and patient safety groups to push the Medical Device Safety Act (MDSA), legislation that would restore the rights of patients who have been harmed by unsafe medical devices to seek justice in state courts.

Last year a Supreme Court ruling gave manufacturers of medical devices immunity from state tort suits if the device has been approved by the FDA’s pre-market approval process. MDSA would restore the right to patients with medical devices, “as Congress has intended in 1976 they passed legislation on medical device safety,” according to AAJ.

Early this month, people with Medtronic cardiac defibrillators implanted in their chests converged on Washington, D.C., to lobby for passage of MDSA. In 1997, Medtronic suspended the sale of its Sprint Fidelis Defibrillator leads after receiving reports of fatalities connected to the devices. The leads were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether. According to last year’s Supreme Court ruling, patients harmed by the defibrillators cannot sue because the medical devices were previously approved by the FDA.

SOURCE: Sprint Fidelis Lead Recall › FDA meeting could compromise Medical Device Safety Act

The recalled devices were manufactured from May 2004 through February 2009 and distributed from May 2004 through February 9, 2009. The defibrillators that fall under the recall have serial numbers in which the last six numbers are under 200000. Defibrillators obtained prior to February 14, 2009 should have serial numbers under 200000 and fall under the recall.

The recall follows a series of letters sent in February and March 2009 to distributors and customers with recommendations and instructions for customers on specific steps to mitigate the identified problems with the device. The February letter instructed customers to replace their batteries every three years. The March follow-up letter instructed customers to download new software for their devices and to remove any battery replacement reminder labels. The new software will detect and prevent potential battery problems that could develop with 123A Lithium batteries in the future.

Software upgrades can be found at www.zollaedplusbatteryhelp.com.

ZOLL will send an email notice to all customers who included their email address as part of their contact information. ZOLL will also publish information about the recall in industry magazines.

Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Source: FDA

SOURCE: Sprint Fidelis Lead Recall › FDA issues Class I recall on ZOLL heart defibrillator

The pressure from the FDA is long coming. In 1990, Congress ordered the more rigorous testing of medical devices before they became available for use, however the FDA never finished implementing the law, getting caught up in a federal loophole that allowed products that are “substantially equivalent” to combinations of other products marketed before 1976 to be sold. Thus, hundreds of new “Class C” devices were approved and made available for use. Class C is the FDA’s most risky category.

Products that currently fall in the Class C category include external heart defibrillators from Medtronic Inc., Royal Phillips Electronics NV and Zoll Medical Corp; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; and a heart pump from Abiomed Inc.

The FDA’s recent action on the measure is spurred by the Government Accountability Office, which criticized the delay last January. The FDA will issue the regulations to the makers of the high-risk medical devices and based on the data, the agency will determine whether to reclassify devices to a less risky category or require the manufacturers to undergo further, more rigorous pre-market testing.

SOURCE: Sprint Fidelis Lead Recall › FDA to crack down on medical device manufacturers

Ron Albrecht

“I don’t trust the unit itself,” he told NWI.com. “You’ve got that fear you’re constantly going to get shocked. It’s very traumatic.”

Because of the faulty defibrillator, Albrecht had to quit his job because he was no longer able to lift heavy equipment. The defective device, he said, has changed his life for the worse.

In 1997, Medtronic suspended sales of its Sprint Fidelis Defibrillators after deaths were linked to the devices. The device’s leads were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether, putting patients’ lives at risk.

Albrecht was one of the many patients who tried to sue Medtronic over his faulty defibrillator leads but previous legislation prevented him and other victims from doing so. Earlier this week, Albrecht and several victims of malfunctioned heart devices converged in Washington, D.C. to lobby for support of the Medical Device Safety Act, which would allow consumers who have been hurt by defective medical devices to sue the device’s maker even if the devices have been approved by the Food and Drug Administration (FDA).

A spokesman with Medtronic says the industry as a whole is resistant to the proposed act, stating that a 1978 federal law was enacted to ensure that the FDA operates as the arbiter of safety.

SOURCE: Sprint Fidelis Lead Recall › Victim of defective defibrillator lobbies for Medical Device Safety Act

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 October 2007, Medtronic suspended the sale of many of its Sprint Fidelis Defibrillator leads after receiving reports of five fatalities connected with the devices. Fractures were found in devices which could cause them to unnecessarily shock patients or fail to work altogether.

The Sprint Fidelis leads 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 defibrillators had been implanted in about 268,000 prior to the suspension, and an estimated 150,000 remain in U.S. patients today. Medtronic and many health experts have advised that the leads not be removed unless the device showed signs of fracturing, as removing the leads can put patients at serious risk.

In its letter to doctors, Medtronic says it hired a panel of independent physicians to study the issue and pore through 89 of the 107 reports sent to the Food and Drug Administration (FDA). The panel found that four of the 13 deaths occurred during procedures to remove the devices.

SOURCE: Sprint Fidelis Lead Recall › Higher number of fatalities connected with Medtronic heart device

Medtronic defended the Minnesota judge on Friday, saying that “this is clearly an effort to remove a well respected judge following rulings the plaintiffs’ lawyers do not like.”

Richard H. Kyle, Jr., works for a Minneapolis based law firm with offices in the Midwest, China, and Mexico. Kyle’s bio on the firm’s website states that he is “a shareholder in [the firm's] White Collar & Regulatory Defense, Health Care Fraud & Compliance and Litigation Groups.”

The website also says that Kyle “is one of the top 40 criminal defense lawyers in Minnesota by the Minnesota Journal of Law and Politics.” Medtronic says that Kyle is not a part of its legal defense and has never represented the company.

Medtronic is the world’s largest medical device manufacturer. Its Sprint Fidelis defibrillators were removed from the market in 2007 because of faulty wires that shocked patients unnecessarily. The defibrillators are blamed for numerous injuries and deaths.

According to the Associated Press, Judge Kyle is “not aware of any formal attempt to remove him from the case.” He also said that that he felt no need to disclose his son’s relationship with the law firm because his son practices criminal law and “would not work with a company like Medtronic.”

Judge Kyle claims that he threw out the lawsuits against Medtronic because the company’s faulty devices had been deemed safe and effective by the Food and Drug Administration. The doctrine of pre-emption, a legal premise that took shape during the Bush administration, allows federal laws to trump state laws. Therefore, since the federal government said that the Sprint Fidelis defibrillators were safe, people harmed by them cannot turn to state law and thus have little or no legal recourse.

Which begs the question: if judges, politicians, and FDA regulators are all attached to big corporations, can the FDA’s stamp of approval on medical devices and drugs ever be trusted to protect the American people?

SOURCE: Sprint Fidelis Lead Recall › Judge tosses medtronic lawsuits, doesn’t disclose son’s ties

As we have reported earlier, a Texas man filed a lawsuit against Medtronic, claiming that his cardioverter defibrillator containing a Sprint Fidelis lead gave him several unexpected and unnecessary shocks, causing excruciating pain and emotional stress.

To ensure that the software update fulfills its purpose and protects patients as it was designed to do, Medtronic will actively monitor the update during actual use.

According to Daniel Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health, Medtronic’s software update “will provide Sprint Fidelis patients with the reassurance that their defibrillator is being monitored around the clock. While the software doesn’t fix the fracture itself, it may help identify the fracture earlier, allowing patients to see their physicians sooner.”

Implantable defibrillators deliver a pulse of energy through a thin electronic wire (the lead) whenever it detects a rhythmic abnormality in the heart. The shock sets the heart back into a normal rhythm.

SOURCE: Sprint Fidelis Lead Recall › FDA approves software update for faulty defibrillator

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

The Wall Street Journal reported Monday that in rare instances, the company’s Riata line of defibrillator leads are poking holes through the hearts of cardiac patients rather than remaining attached to the heart wall.

The leads connect a patients heart to an implantable defibrillator, which helps maintain a proper heart rhythm. The cases have been reported to the Food and Drug Administration.

The newspaper said the most recent cases involve the accounts of four patients and are expected to be posted online Monday by the medical journal Pace.

In October, Medtronic Inc., recalled its Sprint Fidelis lead wires after conceding that the device broke more often than expected and said five deaths may be attributed to the failures. The consumer advocacy group Public Citizen has said the FDA received 27 failure reports on Sprint Fidelis leads in the first two months of 2006. That figure surged to 152 reports during the first two months of 2007.

St. Jude said Monday it has sent a response to the Pace journal, which is expected to be published in the December issue, reaffirming the Riata leads performance and safety. The company said its data show that the incidence rate of perforations with Riata is below or at the low end of what has been reported in clinical literature.

November 12th, 2007

SOURCE: Sprint Fidelis Lead Recall › Safety concerns over defibrillator wires

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

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