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

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

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

Source: FDA

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

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

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

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

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

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

Storms is just one of many individuals who were injured when the Sprint Fidelis leads attached to a defibrillator fractured and malfunctioned. Medtronic voluntarily suspended distribution of the Sprint Fidelis Leads in 2007, the same year Storms’ defibrillator shocked him, after receiving reports of numerous intentional shocks and five deaths related to the faulty leads. Medtronic has since upped the number of deaths linked to the malfunctioning defibrillator leads to 13.

Cardiac defibrillators are placed in patients with life threatening heart conditions to help detect and correct irregular or rapid heart rates. Lead wires attached to the defibrillators and placed in the heart give shocks to correct irregularities detected by the defibrillator. In some individuals with Medtronic devices, the Sprint Fidelis leads have fractured or broken, causing the lead to inappropriately shock the patient or not fire at all.

Following the recall, patients like Storms who were harmed by their devices, began filing lawsuits against Medtronic only to have them thrown out by a judge citing a 2008 Supreme Court precedent that argued that devices that have been approved by the FDA were immune from state tort suits. But all that could change if lawmakers pass the Medical Device Safety Act. The legislation would restore the rights of patients who have been harmed by unsafe medical devices to seek justice in state courts.

Source: Cleveland.com

SOURCE: Sprint Fidelis Lead Recall › Man says faulty defibrillator felt like being kicked by horse

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

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

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

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

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

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

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

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

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

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

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

Source: FDA

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

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

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

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

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

Medtronic recalled the defibrillators in 2007 after five deaths occurred in patients who had the devices implanted in them. 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 recall, Medtronic has increased the number of fatalities linked to the devices to 13.

About 150,000 Americans still have the defibrillators. Medtronic advises patients to discuss with their doctors whether the benefits of removal outweigh the risk, adding that it should be done only as a last resort. Removing the cables can be dangerous. Four patients have already died during the device removal process. Some experts fear that that number will climb if patients don’t seek out skilled doctors at medical centers to perform the extractions.

Finding credible medical centers may also present challenges. Data on the number or the success rates of lead extractions is generally not available to the public.

For those who do choose to have extractions, Medtronic is supplying replacement leads. However, the $15,000 to $20,000 cost of the surgery to remove and implant the new leads is falling on the shoulders of private insurers or Medicare.

SOURCE: Sprint Fidelis Lead Recall › Patients, doctors face tough choice about removing faulty heart devices

Ron Albrecht

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

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

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

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

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

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

The bill was introduced by Democratic Reps. Frank Pallone Jr. of New Jersey and Henry Waxman of California after a Minnesota federal district court dismissed lawsuits filed against Medtronic by 1,496 individuals harmed by their malfunctioning Medtronic defibrillators.

In 1997, Medtronic suspended the sale of many of its Sprint Fidelis Defibrillator leads after receiving reports of fatalities connected to the devices. The devices were found to have fractured, which caused them to unnecessarily shock patients or fail to work altogether.

The patient convergence in Washington, D.C., was accompanied by public service announcements that feature Don Hickey, who was shocked repeatedly by his Medtronic heart device after undergoing surgery. He later found out doctors replaced his defibrillator with the same, defective model. According to the law, he cannot sue the maker of his medical device.

Alternatively, the videoes also feature Diana Levine, who lost her arm from what she calls faulty labeling of a drug by its manufacturer. She successfully sued both her doctor and the drug company. The injustice she sees is that people, like her, who have been harmed by pharmaceutical companies, can seek justice in court, whereas individuals like Hickey who have been harmed by faulty medical devices, cannot.

“If you can’t hold a corporation responsible when a product with FDA approval hurts you, that’s like giving a corporation a license to hit and run,” Levine told The Minnesota Independent. “What’s really crazy is now there are two laws. The Supreme Court has said that people like me who are hurt by bad drugs can sue. But people like Don who are hurt by bad medical devices cannot. It’s time we finish the job. We need to all work together to pass the Medical Device Safety Act.”

SOURCE: Sprint Fidelis Lead Recall › Patients converge on Capital Hill for right to sue Medtronic

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

The Sprint Fidelis leads connect electrical defibrillators to the hearts of patients with aberrant cardiac rhythms and deliver a jolt to the heart as needed to return the heartbeat to a normal rhythm. The defibrillators had been implanted in about 268,000 prior to the suspension, and an estimated 150,000 remain in U.S. patients today. Medtronic and many health experts have advised that the leads not be removed unless the device showed signs of fracturing, as removing the leads can put patients at serious risk.

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

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

A new study published Monday in the Heart Rhythm medical journal suggests that the more than 200,000 recipients of  Medtronic heart defibrillator leads may be at a greater risk than previously thought.

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

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

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

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

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

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

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