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“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.
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.
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.
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 the matter In Re MEDTRONIC, INC., SPRINT FIDELIS LEAD PRODUCT LIABILITY LITIGATION.
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 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.
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.
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).
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.
Congressional dems seek reversal of Supreme Court DecisionA 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.
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