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 reviewing 30 months of data from two current studies following their implanted heart device that 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.
Our medical device litigation team is actively investigating cases involving injury from Medtronic Sprint Fidelis leads and would be happy to discuss associating with you on any of your cases.
For more information on the Medtronic Sprint Fidelis defibrillation leads and/or case intake and evaluation, please contact Jon L. Gelman at (973) 696-7900.
The New York Times
Patients Warned as Maker Halts Sale of Heart Implant Part
Medtronic News Release
Medtronic: Important Information About the Sprint Fidelis® Defibrillator Lead
St. Jude Defibrillator Wire Gets Scrutiny
New Accounts of Patients With Heart Perforations Are Set to Be Published