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Sprint Fidelis 30 articles

Man says faulty defibrillator felt like being kicked by horse

“It felt like having a horse inside you trying to kick its way out of your chest,” says Bill Storms of Delaware, Ohio, describing what it felt like when the Medtronic cardiac defibrillator implanted in his chest began malfunctioning and sending electrical jolts through his body. The 38-year-old truck driver said his device misfired 138 times over a five-hour period before the device was eventually turned off. 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, ... Read More

Medtronic informs doctors of faulty pacemakers; Letter to patients to follow

Medical device maker Medtronic sent a letter to doctors worldwide earlier this month warning that nearly 37,000 of its Sigma and Kappa pacemakers, most manufactured between November 2000 and November 2002, could have faulty wiring that can cause the pacemakers to work improperly or not at all. This defect can be deadly for the estimated 1.7 million people who have pacemakers implanted in their chests. 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 ... Read More

Alabama man injured by cardiac defibrillator sues manufacturer

Beasley Allen Law Firm attorneys P. Leigh O’Dell and Ted G. Meadows filed a lawsuit on April 29, 2009, on behalf of Patrick M. Lancaster of Alabama, alleging that the plaintiff suffered injuries as a result of having been implanted with a Sprint Fidelis Lead manufactured by Medtronic, Inc. The lawsuit names defendants Medtronic Inc., Medtronic Puerto Rico, Inc., and Medtronic Puerto Rico Operations Co. 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 ... Read More

FDA meeting could compromise Medical Device Safety Act

The Food and Drug Administration (FDA) has planned an internal meeting today to discuss the strategic direction of the agency’s medical device center, adding fuel to concerns that the government agency carelessly approved medical devices and as a result put patients’ health and safety at risk, according to the American Association for Justice (AAJ). 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, ... Read More

Patients, doctors face tough choice about removing faulty heart devices

Doctors and their patients with recalled Medtronic defibrillators implanted in their chests may soon be faced with making difficult decisions about whether to undergo life-threatening surgery to remove the faulty heart devices to prevent possibly fatal events, according to the New York Times. 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 ... Read More

Victim of defective defibrillator lobbies for Medical Device Safety Act

Ron Albrecht lives in fear – fear that one day he will learn that the defibrillator implanted in his chest is defective and will cause him excruciating pain when it fails, like his previous one did two years ago. That device turned out to be among the defective heart defibrillators that were recalled by the device’s manufacturer, Medtronic. Albrecht’s device had to be replaced, and while his new one appears to be operating fine, he still worries. “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 ... Read More

Patients converge on Capital Hill for right to sue Medtronic

People with Medtronic cardiac defibrillators implanted in their chests converged on Washington, D.C., this week to lobby for the passage of the Medical Device Safety Act. The act will 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). 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 ... Read More

Higher number of fatalities connected with Medtronic heart device

Medtronic Inc. has issued a letter to doctors stating that a defective lead wire in its popular heart defibrillator, which was recalled in October 2007, may have contributed to the deaths of 13 individuals in which the heart devices were implanted, according to the Star Tribune. That death toll is up from the medical device company’s original estimate two years ago of five deaths. 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 ... Read More

Study shows heart leads may fail as they age

Congressional dems seek reversal of Supreme Court Decision 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 ... Read More

Judge tosses medtronic lawsuits, doesn’t disclose son’s ties

U.S. District Judge Richard Kyle dismissed thousands of lawsuits against Medtronic Inc., manufacturer of the faulty Sprint Fidelis defibrillators that have allegedly injured and killed several people. Attorneys serving the patients, however, may seek to have the judge disqualified from the case because he never disclosed that his son works for the law firm representing Medtronic. Medtronic defended the Minnesota judge on Friday, saying that “this is clearly an effort to remove a well respected judge following rulings the plaintiffs’ lawyers do not like.” Richard H. Kyle, Jr., works for a Minneapolis based law firm with offices in the Midwest, ... Read More