On October 15, 2007, Medtronic suspended sale of their Sprint Fidelis Defibrillator leads (Models 6930, 6931, 6948, 6949) after receiving reports of 5 fatalities.
Reports of fracturing of Sprint Fidelis leads on Medtronic implantable defibrillators had been piling up for months. As of January 2007, the Food & Drug Administration (FDA) had received 599 reports of lead fractures.
In March 2007, Medtronic wrote a letter to doctors warning them about possible problems with the defective leads. However, it was a full 6 months later before the company decided to postpone distribution on the Sprint Fidelis leads.
Despite having so many reports of Sprint Fidelis lead fractures, the FDA did not start monitoring the component until February, after the Minneapolis Heart Institute published a study of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models, another type of Medtronic lead.
Unexpected and inappropriate shocks to the heart caused by a defective cardiac defibrillator caused one man to suffer such severe anxiety that he is now being treated by a psychiatrist for post traumatic stress, according to The Southeast Texas Record. The patient, Donald Larry Jackson, filed a product liability suit against Medtronic, the makers of the defective medical device, and is seeking claims of relief for product liability, breach of implied warranty, negligence, intentional infliction of emotional distress, negligent infliction of emotional distress, violation of consumer protection statutes, breach of express warranties, unjust enrichment, battery, and negligent misrepresentation. Jackson underwent ... Read More
The Food and Drug Administration (FDA) has issued an alert to patients just two weeks after Medtronic, Inc. sent separate letters to health care professionals and patients worldwide warning that thousands of its pacemakers could have faulty wiring that can cause the medical devices to work improperly or not work at all. This defect could have potentially deadly consequences for patients with the devices. 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 ... Read More
The House Energy and Commerce Health Subcommittee continues to debate the Medical Device Safety Act of 2009, with the announcement of a June 18 hearing on the matter. The bill proposes to overturn the Supreme Court ruling of Riegel v. Medtronic, Inc., which prevents consumers who have been hurt by defective medical devices to sue the device’s maker if the devices have been approved by the Food and Drug Administration (FDA). The class includes medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, coronary artery stents and pre-filled syringes. According to an internal FDA document, senior officials with the ... Read More
“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
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
President Barack Obama’s top pick for Food and Drug Administration (FDA) commissioner, Bioterrorsim expert and former New York City health commissioner Dr. Margaret Hamburg, says if confirmed she would “create a culture (at the agency) that would enable all voices to be heard,” according to Thompson, a human resources Web site. The comment was made during a question-and-answer exchange with Sen. Barbara Mikulski (D-Md) during the 1 ½-hour confirmation hearing. 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 ... Read More
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
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
Another heart defibrillator has fallen under a Class I recall by the Food and Drug Administration (FDA). The recall on ZOLL AED Plus Defibrillators was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. 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 ... Read More
The Food and Drug Administration (FDA) is cracking down on makers of medical devices that fall in the most risky category of products approved by the FDA, ordering the companies to provide tougher evidence of their products’ safety and effectiveness or pay for extensive clinical trials for their products currently on the market, according to the Wall Street Journal. 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 ... Read More