Sprint Fidelis Defect Medtronic Defibrillators

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Sprint Fidelis Defect - Medtronic Defibrillators

Medtronic Inc. is the largest maker of implantable cardioverter defibrillators (ICDs) and pacemakers. On February 11, 2005, the FDA announced Medtronic was issuing a safety warning because of a potential battery shorting mechanism that could occur in some of its ICD devices. According to the notification letter sent to physicians, the company reported that nine batteries experienced rapid battery depletion due to the shorting action among the Medtronic defibrillators. The danger among shorting Medtronic defibrillators is that it could cause the battery to deplete within a few hours to a few days, resulting in a complete loss of device function.

Affected Medtronic Defibrillators

Affected Medtronic defibrillators included devices manufactured between April 2001 and December 2003 in subsets of:

the Marquis VR/DR
Maximo VR/DR ICD models
InSync I/II/III Marquis and
InSync III Protect CRT-D devices.

Roughly 75 percent of the potentially defective Medtronic defibrillators were implanted in the United States. The Medtronic defibrillator warnings came as the industry was pushing to increase the number of implants after a study showed 80 percent of heart patients who could benefit from ICDs do not have one.

Defibrillator Recalls

After a series of defibrillator and heart device recalls and safety warnings, the Public Citizen consumer group petitioned the FDA to change the current system, allowing companies to delay the removal of a flawed device. Doctors continue to use the remaining inventory despite changes in flawed devices in order to deplete inventory of older, defective devices, and problems among Medtronic defibrillators, as well as Guidant Corp. and St. Judge Medical Inc.’s devices – the number two and three makers of ICDs, was evidence, according to the consumer group, of company profits being put ahead of patient safety.

Defibrillators are special medical implants with significant lifesaving capabilities. Therefore, when a defect is present, the results can be devastating. The FDA has been criticized for failing to require special oversight of the essential medical devices, allowing the majority to be placed on the market without requiring clinical testing as long as they were “substantially equivalent” to previously marketed devices.

In 2005, after the top three defibrillator manufacturers issued massive recalls and safety warnings, two U.S. lawmakers said they planned on increasing scrutiny of the FDA and its processes because of “FDA incompetence and a lack of diligence,” according to U.S. Rep. Edward Markey.

Contact a Medtronic Lawyer for more information on the Medtronic defibrillators recall.

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