Medtronic Lawsuit

On October 22, 2007, Congressman Henry Waxman, Chairman of the Committee on Oversight and Government Reform, sent a letter to FDA Commissioner Andrew von Eschenbach in which he requested information about the FDA’s approval of Medtronic’s Sprint Fidelis leads.
Congressman Waxman also requested information from Medtronic, Inc. about when and what the company reported to the […]

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Dr. Robert Hauser of the Minneapolis Heart Institute describes the experience for patients of being jolted by an implantable cardiac defibrillator like being kicked in the chest by a horse, according to an article published October 16, 2007 by Christopher Snowbeck of the Pioneer Press.  The flaw acknowledged by Fridley-based Medtronic involving a lead wire commonly […]

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A recent defibrillator recall has triggered the Food and Drug Administration (FDA) to necessitate additional testing of crucial heart device components prior to their availability for consumption. This concern stemmed from Medtronic’s recent dilemma with its Fidelis lead. The company’s representative announced that Medtronic projected that Fidelis will achieve its intended purpose as previous prototypes.
Ms. […]

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Another faulty product may possibly be a contributing factor to the cause of five deaths and still counting. Medtronic, the maker of implanted heart devices, recommended that doctors cease from using the Medtronic defibrillators with Fidelis lead. Recent reports of fractures in the electrical “lead”, a wire that connects the heart to a defibrillator implanted […]

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As a result of the serious problems and injuries related to the Medtronic Sprint Fidelis defibrillator leads, the FDA may require more extensive testing of heart device components before they are sold to the public.  The FDA is going to examine whether the tests that Medtronic performed with regard to the Sprint Fidelis defibrillator leads […]

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