Unexpected and inappropriate shocks to the heart

Jackson underwent emergency surgery to replace the defibrillator but continued to have anxiety from the experience. He says he is now at an increased risk of cardiovascular events or death because of the inappropriate shocks to his heart, which is causing him pain, extreme anxiety, fear of death and great physical, emotional and psychological suffering.

Jackson’s case is one of several that have come to light over the years after patients reported experiencing sometimes excruciatingly painful electric shocks in their chest. Certain models of the leads, which connect to the defibrillators, were found to have fractured, causing the defibrillators to unnecessarily shock patients or fail to work altogether. As a result, on October 15, 2007, Medtronic suspended the sale of its Sprint Fidelis Defibrillator Leads. To date, Medtronic has reported 13 fatalities associated with the faulty leads.

Jackson’s complaint contends that Medtronic did not provide him with notice of the increased fracturing risk and made unconscionable or fraudulent representations regarding the product.

SOURCE: Sprint Fidelis Lead Recall › Texas man suffers from PTSD from defective cardiac defibrillator

The defect involves a separation of wires that connect to the electronic circuit to the pacemaker components. Patients with the defective devices reported feeling faint or lightheaded. Medtronic has received two reports of patient deaths that may be a result of the faulty pacemakers.

An estimated 15,200 active Kappa devices and 6,100 active Sigma devices are affected by the issue. 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. The company predicts failure rates of 1.1 percent for the Kappa pacemaker and 4.8 percent for the Sigma pacemaker over the remaining lifetime of the pacemakers because of the defect.

In accordance with the HRS recommendations on device advisory communications, Medtronic will begin informing patients with registered devices that fall within the above mentioned parameters with a letter dated May 27, 2009. The letter will advise patients to contact their physician for more information.

The warning comes on the heels of a massive recall of Medtronic’s Sprint Fidelis Defibrillator leads because of reports of fractures in the leads which can result in the defibrillators to unnecessarily shock patients or fail to work altogether. To date, the Sprint Fidelis Defibrillator leads defects have been blamed on at least 13 deaths.

Source: Medtronic

SOURCE: Sprint Fidelis Lead Recall › Medtronic informs doctors of faulty pacemakers; Letter to patients to follow

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

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

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

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

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

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

January 2nd, 2008 by Staff with NewsInferno.com

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

Medtronic suspended sales of the Sprint Fidelis Leads 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

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