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Medtronic Heart Implant Device

On October 14, 2007, Medtronic, the nation's largest heart implant device manufacturer, announced a defect in the critical electrical "lead" or wire connecting the heart to several of its defibrillator models.   The defect in this electrical wire, called the Sprint Fidelis, has resulted in hundreds of malfunctions and may have contributed to the death of at least five patients.

Since 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.

As part of the warning, Medtronic estimated that approximately 4,000-5,000 or 2.3 percent of patients with the defective Sprint Fidelis lead would experience a lead fracture within 30 months of implantation.  Medtronic is encouraging all doctors to stop implanting the Sprint Fidelis lead.  The company will pay for replacements for fractured leads and $800 towards medical expenses, but will not compensate patients wanting to replace functioning leads to prevent future fractures. In addition, Medtronic has discontinued sale of the Sprint Fidelis lead and will recall all leads not in use.

If you have been told that your Medtronic defibrillator lead needs to be replaced or if you want more information on your legal rights and options, please contact us.