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

The complaint incorporates by reference the relevant portions of the Master Consolidated Complaint for Individuals on file with the Clerk of the Court for the United States District Court for the District of Minnesota in the matter In Re MEDTRONIC, INC., SPRINT FIDELIS LEAD PRODUCT LIABILITY LITIGATION.

According to the complaint, Lancaster received the Sprint Fidelis lead on May 10, 2007 at DCH Regional Medical Center in Tuscaloosa, Alabama. As a result of the lead, Landcaster suffered injury and damages.

On October 15, 2007, Medtronic suspended the sale of its Sprint Fidelis Defibrillator Leads after receiving reports of fatalities associated with the defibrillators. It was discovered that the Sprint Fidelis leads, or cables that connected to the devices, had fractured, causing the defibrillators to unnecessarily shock patients or fail to work all together. Since the initial recall, Medtronic has increased the number of fatalities associated with the faulty leads to 13.

Due to a Supreme Court ruling last year, manufacturers of medical devices that have been approved by the FDA are immune to lawsuits by victims harmed by those devices. Currently, consumer and patient safety groups are working to push the Medical Device Safety Act (MDSA), legislation that would restore the rights of patients who have been harmed by unsafe medical devices, such as Lancaster, to seek justice in state courts.

Read the complaint.

SOURCE: Sprint Fidelis Lead Recall › Alabama man injured by cardiac defibrillator sues manufacturer

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

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

Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the leading natural cause of death in the U.S. In February 2005, Medtronic warned of a potential battery shorting problem in various Marquis-brand defibrillators. According to the Wall Street Journal, 11,000 of the machines were surgically removed and replaced with a different device in the U.S. and 2,000 more such removals took place overseas. The Food & Drug Administration (FDA) classified Medtronic’s action as a Class II recall. In a Class II recall, there is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems.

Plaintiffs in the suits against Medtronic argued that the company knew for years that there was a potential for product defects but sold its stock of potentially defective devices and didn’t advise patients that safer devices were available. The company has argued that it fulfilled every obligation in terms of reporting the problem, including seeking and receiving FDA approval in 2003 to implement battery design changes. Yet in spite its claims that it acted properly, Medtronic is now settling thousands of defective Marquis Defibrillator Lawsuits. The company will pay a total of $114 million, as it settles 2,682 cases for $95.6 million as well as $18.5 million in attorneys’ fee.

Medtronic, the largest manufacturer of ICDs, has had other problems with many of its devices. In April 2004 Medtronic announced that it was recalling its Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 ICDs after they had been linked to at least four deaths and one injury. Medtronic said at the time that some of the recalled defibrillators failed to charge properly, resulting in the late delivery or no delivery of cardiac shock therapy. In January 2007 the FDA announced that the agency started an investigation looking into accusations by a former Medtronic engineer that the medical-device company didn’t sufficiently test its new Concerto cardiac device for patients with congestive heart failure. The Concerto device is one that can resynchronize the heartbeat of a patient and also provide backup defibrillator capability to save the patient’s life if the heart goes into cardiac arrest.

In October 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

January 1st, 2008 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic settles defective defibrillator lawsuits for $114 Million

His implanted cardiac defibrillator (ICD) had sent 800 volts of electricity into his heart muscle, a jolt doctors compare to being kicked by a horse. Then it did it again. And again.

“I was hollering every time it hit me,” Jackson said. “It hit me six times … it’s a good wallop. I began to think it wasn’t going to stop.”

As their granddaughter screamed, Mattie Jackson called 911. She assumed her husband was suffering from an extreme rapid heartbeat, a life-threatening episode he had experienced twice in 2004.

The ICD was implanted to shock Jackson when his heartbeat speeds out of control. Instead, it seemed to be killing him.

“I was terrified,” said Mrs. Jackson, her eyes watering as she recalled him shrieking in pain.
At the hospital, doctors found that a wire, or “lead,” running from the matchbox-size defibrillator under his collarbone, had broken inside his heart. The two fractured ends had caused a false electrical impulse and triggered the ICD to shock him.

“It was telling the defibrillator something was happening, so it just went shooting out those pulses,” Jackson explained. “It thought something had happened to my heart.”
He was wheeled into emergency surgery the next morning.

“They took me in, cut me open, pulled out the defibrillator, pulled the wire out and put a new wire (and defibrillator) in,” he said.

Despite his surprise at the ordeal, Jackson said his experience wasn’t a fluke.

He and some 235,000 people worldwide received word in October from Medtronic Inc., the world’s largest ICD maker, saying the wire lead threaded into their hearts to deliver shocks at 800 volts a pop was recalled from the market because of its tendency to fracture.

The Sprint Fidelis lead, a newer streamlined wire issued by Medtronic, was fracturing at a rate of 2.3 percent in 30 months, twice the rate of its predecessor.

Medtronic urged patients to visit their cardiologists and have the defibrillators programmed for tighter self-check alerts. Jackson was one of dozens who met with his cardiologist, Dr. Alex Petrakian of Cardiovascular Associates of East Texas.

Petrakian said Medtronic underestimated the faulty wire’s effect, as he noticed problems much earlier than October, and with more frequency. Of his 65 patients implanted with a Sprint Fidelis lead, Jackson was the eighth to present with a fracture.

“We noticed a problem with that wire before they recalled it, so I stopped using it (in July),” Petrakian said. “It was unusual that there were reports from all over the country about docs having the same problems.”

The possibility of a fracture is frightening, he said. While Jackson was shocked six times, others suffering lead fractures have been shocked double or triple that number.

“Sometimes they present to the hospital after having 20 or 30 shocks,” Petrakian said. “Medtronic said those shocks have actually killed; the shocks themselves have caused the heart to stop.”

Complicating the recall is the recommendation that patients with ICDs not have them surgically removed until they malfunction.

“We don’t recommend going in and replacing those wires if they’re not fractured, because of the risk of the procedure itself, risk of infection and other complications,” Petrakian said.

Scar tissue can quickly envelope a lead, which is threaded into one of the heart’s lower right chambers and screwed into the heart muscle, he said.

Instead of invasive remedies, Medtronic is urging closer monitoring of those Sprint Fidelis patients and is footing the bill for the co-pays, procedures and recovery of complications of related fractures, said Medtronic spokesman Rob Clark.

“This is one of the largest actions ever taken,” Clark said. “We did it proactively, so patients who have Fidelis leads could go into a physician and, in most cases, can have the device reprogrammed; any fractures or weakening that develops, they’ll be able to see that in advance so appropriate action can be taken.”

But 64-year-old Athens resident Ruby Barrett said that doesn’t come close to allaying her fears.

Her ICD (and its recalled lead) was implanted just 39 days prior to Medtronic’s announcement. She was sickened by the news of the recall, she said, and feels helpless, like she’s waiting for her ICD to malfunction.

“I hope to God not, but if anything goes wrong in there I’m probably going to die,” said Barrett, who suffers from congestive heart failure. “I don’t want to go out of here being shocked to death.”

ICDs are revolutionary treatment for patients prone to irregular, slow or fast heartbeats that put them at risk for sudden cardiac arrest. Medtronic estimates some 15,000 people have received life-saving shocks since the equipment’s inception.

Petrakian said he and other cardiovascular surgeons implant some 500 to 600 ICDs each year in East Texas. But the wear and tear on leads is great, he said; the heart is a volatile space.

“Leads don’t last forever,” Petrakian said. “With every heartbeat, the lead is moving. It flexes back and forth, and so you can just imagine, flexing back and forth millions of times puts pressure on the lead.”

Clark agreed. The lead’s design, manipulation of the lead during the implantation procedure, the harsh environment of the heart and the patient’s body type can all contribute to the equipment’s viability, he said.

Medtronic, a $12.3 billion company, reported a 16 percent sales drop in its 2007 fiscal second quarter, about a $150 to $200 million loss, Clark estimated.

But Medtronic is no stranger to working out equipment flaws. This month, the company agreed to spend $114 million to settle 2,682 lawsuits related to an earlier line of ICDs that suffered a potential battery shorting problem announced in February 2005.

Petrakian said a handful of his patients are considering legal action after October’s recall, but said most of it is due to anxiety.

“I’d be anxious about it,” he said. “Having a recalled lead, especially if the incidence is that high.”

Mrs. Jackson said she’s just relieved the lead is gone from her husband’s chest. She’s glad to have gotten through it.

“If it wasn’t for our church family, God, prayer,” she said, “I don’t know what we would have done.”

December 27th, 2007 by LAUREN GROVER with Tyler Paper.com

SOURCE: Sprint Fidelis Lead Recall › Recalled heart implant gives man shock of his life

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

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

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

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

But the October settlement was not the end of Medtronic’s defibrillator woes. That same month, Medtronic suspended sales of the Sprint Fidelis Leads after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. It is through the lead that a defibrillator is able to sense when a patient’s heart rhythm is out of sync. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

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

December 10th, 2007 by Staff with NewsInferno.com

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

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

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 lawsuits were filed against Minnesota-based Medtronic by Kenneth Carlile of Kansas City and Phillip S. Brown, a Johnson County resident.

The complainants contend that Medtronic was negligent in its design of electronic wires – known as SprintFidelis leads – that connect the defibrillators to patients’ hearts.

Medtronic in October voluntarily recalled the Sprint Fidelis wires because they can fracture, which causes them to give unnecessary shocks or not function at all. Medtronic said it had identified five patient deaths “in which a Sprint Fidelis lead may have been a possible or likely contributing factor.”

The Carlile lawsuit was filed in federal court in Kansas City and the Brown lawsuit was filed in federal court in Kansas City, Kan. Carlile received his implantation at the University of Kansas Hospital in November 2004, and Brown received his implantation at Menorah Medical Center in Overland Park in August. The hospitals are not defendants in the lawsuits.

Each lawsuit contains six counts, including allegations of negligence and failure to warn patients of problems with the Sprint Fidelis wires earlier.

Medtronic spokesman Rob Clark said the company did not comment on the specifics of litigation filed against it, adding that lawsuits could be expected when the company recalled products.

November 12th, 2007

SOURCE: Sprint Fidelis Lead Recall › Two men sue company over design of defibrillator

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

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