Medtronic Defibrillator

Medtronic Announces Defect in Sprint Fidelis Defibrillation Leads

On October 14, 2007, Medtronic, the nation's largest heart implant device manufacturer, announced a defect in the critical electrical "lead" component of its heart defibrillator. The New York Times reported on October 15, 2007, that the defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have played a role in the death of five Medtronic defibrillator patients.

In a news release published by Medtronic, the company says that since the Sprint Fidelis lead was introduced in 2004, approximately 268,000 patients in the United States have been implanted with the lead as part of the Medtronic defibrillator. Affected models of the Sprint Fidelis defibrillation leads are 6930, 6931, 6948 and 6949. All patients who have received the Medtronic defibrillator since 2004 are urged to visit their doctor to check for potential fractures. A fracture in the lead can cause the device to misread heart rhythms, sending unnecessary, painful shocks to patients or worse, failing to provide a vital life-saving shock.

As part of the warning, Medtronic estimated that approximately 4,000-5,000 people with the defective Sprint Fidelis lead would experience a lead fracture within 30 months of implantation. Medtronic made the announcement after questions arose from reports, including one by the Minneapolis Heart Institute, and after a review of 30 months of data from two current studies following their implanted heart device showed several fracture problems.

As the New York Times reported, in conjunction with the announcement, Medtronic is encouraging all doctors to stop the use of the Sprint Fidelis lead in patients using its defibrillators. The company will pay for replacements for fractured leads and $800 towards medical expenses, but will not compensate patients wanting to replace of properly functioning leads to prevent future fractures. In addition, Medtronic has stopped the sale of the Sprint Fidelis lead and will recall all leads not in use. The Food and Drug Administration has endorsed the recall.

The Motley Rice medical device litigation team is actively investigating cases involving injury from Medtronic Sprint Fidelis leads and has litigated against Medtronic in recent defibrillator and tissue cases.

For more information on the Medtronic Sprint Fidelis defibrillation leads, please contact Motley Rice attorney Rhett Klok at (843) 216-9218.

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Medtronic Defibrillator may experience rapid battery depletion.

Medtronic, Inc., has voluntarily advised physicians about a potential battery shorting mechanism that may occur in a subset of implantable cardioverter-defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) models.

In a letter to physicians, Medtronic reported that nine batteries (0.01 percent or approximately 1 in 10,000) have experienced rapid battery depletion due to this shorting action. If shorting occurs, battery depletion can take place within a few hours to a few days, after which there is loss of device function. There are no reported patient injuries or deaths.

Devices with batteries manufactured between April 2001 and December 2003 may exhibit this shorting action. Potentially affected models are the Marquis VR/DR and Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D devices.

Approximately 75 percent of these devices were implanted in the United States. Patients with other models of Medtronic devices or these device models with batteries manufactured after December 2003 are not affected.

As part of the company's program to analyze products returned from physicians, Medtronic identified nine of 87,000 implanted devices (0.01 percent) with a battery design that exhibited this shorting mechanism. Based on highly accelerated company testing, Medtronic estimates that this rate may increase up to between 0.2 percent and 1.5 percent over the second half of device life.

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