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

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis Leads are being told to leave the defective components in place unless they fracture.

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

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

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

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

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

January 2nd, 2008 by Staff with NewsInferno.com

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

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

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. Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear.

Lead replacement is also an expensive procedure, and can cost in excess of $12,000. And even though it made the defective Sprint Fidelis Lead that is now causing so many patients so much anxiety, Medtronic is doing little to absorb the costs of lead replacement. When it first announced the Sprint Fidelis Lead recall in October, Medtronic said would cover the cost of a new lead, as well as pay $800 in medical costs for patients whose lead had fractured. But later, the company extended that coverage to patients without fractures, in cases where doctors advise removing the leads because of the patient’s specific medical condition. Even with Medtronic’s contribution, however, patients who have their Sprint Fidelis leads replaced could still be left with a large medical bill. So far insurers are deciding whether to cover the replacement operation on a case-by-case basis, unless the lead has already fractured.

Patients whose doctors don’t recommend the removal of the Sprint Fidelis Lead have little choice to wait and hope it does not fail. Their defibrillators will need to be reprogrammed and monitored, to improve the odds of catching any developing fractures early. But this precaution does not come with a guarantee that all Sprint Fidelis Lead failures will be caught before a patient is injured, and the component could still fracture without warning.

The number of people left to worry that their Sprint Fidelis Lead will one day fracture is staggering. 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. It will be a long time – if ever – before all of these Sprint Fidelis Lead patients can feel secure.

December 12th, 2007 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Sprint Fidelis defibrillator lead patients faced with difficult dilemma

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

It was reported yesterday in the Wall Street Journal that the global medical device manufacturer acknowledged the federal investigations as part of a filing with the SEC (Securities and Exchange Commission).On October 15, 2007, a nationwide Medtronic recall was issued for all models of the Sprint Fidelis defibrillator lead. Defects in the lead could cause the thin electrical wire to fracture or break, resulting in electrical shock or device failure.

A lot of controversy has surrounded the approval of this device by the FDA, since no specific testing was required before it was introduced in 2004. In addition, many have expressed concerns about the timing of the defibrillator lead recall, as the Company delayed removal of the device from the market for many months, allowing thousands of people to receive the lead which was known to be dangerous and defective.

Medtronics indicates that the Senate Finance Committee has requested information regarding the defibrillator lead recall as well as information about alleged payments made to doctors by the company. Shortly after the recall, the company was also the subject of a letter from the U.S. Congressional Committee on Oversight and Government Reform, which was sent to the commissioner of the FDA inquiring about the Sprint Fidelis lead’s approval process and when the FDA first learned about the risk that the leads could fracture.

A separate Medtronic investigation has been initiated by the Justice Department, through the U.S. attorney’s office for the Eastern District of Pennsylvania. The U.S. attorney requested that the company provide information about payments made to doctors outside of the United States. The alleged payments could be in violation off the U.S. Foreign Corrupt Practices Act, which is designed to prevent companies from bribing foreign government officials.

Any defibrillators implanted since 2004 could have the Sprint Fidelis lead. To determine if you, a friend or family member may be impacted by the recall, contact your doctor for medical advice and contact our office for a free legal consultation.

December 6th, 2007 by Austin Kirk with Permalink

SOURCE: Sprint Fidelis Lead Recall › Medtronic investigations initiated by federal government

Following the recall, it was learned that Medtronic had been receiving reports that indicated the Sprint Fidelis Lead had a higher-than-normal fracture rate for months. The incident has raised questions about the Food & Drug Administration’s (FDA) regulation of medical devices, and of the Medtronic’s response to early reports of lead problems.

Medtronic has acknowledged in a Securities and Exchange Commission (SEC) filing that the Senate Finance Committee has requested information about ties between the medical-device industry and practicing physicians and information about Medtronic’s suspended distribution of its Sprint Fidelis family of defibrillation leads. The Senate panel is probing the FDA’s oversight of medical-device components.

Medtronic said in the same SEC filing that it is the subject of a Justice Department probe into illegal physician payments. The U.S. attorney’s office for the Eastern District of Pennsylvania asked for information on payments or gifts to physicians or physician’s groups related to the purchase of the company’s cardiac stents and cardiac-therapy devices.

The U.S. attorney also asked Medtronic to provide documents related to its relationship with a specific customer. The customer wasn’t identified in the SEC filing. In September, the SEC began an informal probe of Medtronic, seeking information about possible violations of the Corrupt Foreign Practices Act, which is meant to stop bribes to foreign officials.

This is not the first time Medtronic’s relationships with physicians has come under scrutiny. Earlier this year, Sen. Charles Grassley, R-Iowa, requested information from Medtronic about the company’s payments to orthopedic surgeons, and questioned whether they improperly influenced physician decisions about which products to use.

Monetary agreements with physician consultants are common in the medical device industry, where doctors are paid for their work developing products and then, in some cases, for helping to train other doctors in how to use the products. Medtronic insists that it only provides physicians with compensation that is fair, relative to current market values, and is compliant with the law.

December 6th, 2007 by Staff with NewsInferno.com

SOURCE: Sprint Fidelis Lead Recall › Medtronic faces investigations over defective Sprint Fidelis Defibrillator lead

Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead fractures. A lead is a wire that connects an implantable defibrillator to the heart. When it breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.

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

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

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

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

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

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

November 23rd, 2007

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

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

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