The Sprint Fidelis lead, an electrical cable that connects an implanted defibrillator to a patient’s heart, was recalled by Medtronic, Inc. in October 2007 after being linked to multiple patient deaths. Investigators discovered a defect in the Sprint Fidelis implant which can cause the defibrillator to misfire and in some cases, severely shock the patient. On Friday, March 13, 2009, Medtronic released a statement that placed the number of fatalities that have come as a direct result of the heart implant defect at a minimum of thirteen. This number is a substantial jump from the five deaths they originally cited at the time of the recall. In addition to these fatalities, there have been around 2,200 reports of serious injury related to the Sprint Fidelis lead.

New evidence suggests that Medtronic, Inc. knew of the defect years before they informed the public. Further developments in the ongoing heart implant recalls of Medtronic, Inc. could prove crucial to the rising number of lawsuits filed against the company. Houssiere, Durant & Houssiere, LLP, represents heart patients, from seniors to children, who received defective defibrillator leads manufactured by Medtronic, Inc. The experienced heart implant attorneys at HDH are evaluating all potential Medtronic heart implant recall cases.

A study published February 23rd 2009 indicates that the failure rate of the Sprint Fidelis lead may be much more serious than Medtronic, Inc. had initially estimated. The study was performed by Dr. Robert G. Hauser of the Minneapolis Heart Institute and Dr. David L. Hayes of the Mayo Clinic. Based on an observation of 3,000 patients, the Sprint Fidelis lead had an annual failure rate of 3.75% compared with 0.6% for other leads. After three years, the device was functioning properly only 88% of the time. “The hazard of the Sprint Fidelis lead is increasing, while the failure rate of other defibrillator leads are low and stable,” the two cardiologists wrote.

Medtronic, Inc. and heart experts both agree that due to the risks involved in the procedure, functioning leads should not be removed as a precaution. The new report also suggested that removal of the Fidelis lead might be appropriate only if the benefits clearly outweighed the risks.

The New York Times estimates that over 150,000 people int his country still have the Sprint Fidelis leads int heir bodies. If you or someone you know has had a Medtronic heart implant surgically implanted and believe it has failed, was defective, needs to be removed, or has already been revised, you should have your potential defective heart implant case reviewed by the experienced heart implant recall attorneys at Houssiere, Durant & Houssiere, LLP. If you do not know if your heart implant is a Medtronic heart manufactured by Medtronic, Inc., call your surgeon and get a copy of your hospital medical chart.