Medtronic, Inc. recently suspended worldwide sales of one of their products-Sprint Fidelis defibrillation lead because of increased risk of lead fractures. Supposedly, they knew of defects in the producr prior to the recall.They had been selling this product since 2004. The fracture in the lead apparently can cause shock to the patient or cause the defibrillator not to operate whatsoever. The Medtronic Sprint Fidelis lead is also used by manufaturers other than Medtronic. The model numbers for the defective leads are 6930, 6931, 6948, & 6949. Medtronics has acknowledged that approximately 5,000 people will experience lead fracture with 30 months of the implkant procedure. Thousands of consumers are at risk for failure of the product. The options are to leave the implant in the body or have high risk replacement surgery. The FDA has not recommended the removal by surgery because of the hig risk. Younger patients appear to be even at a greater risk. This is yet another in a long line of products that have been shown to increase risk to patients including Vioxx, Fen-Phen, Rezulin, Phenylpropanolmine, Propulsid, Ephedra, Baycol, Breast Implants and tainted blood. If you have any questions regarding these products please consult with us as we have co-counsel arrangements with large firms who are actively involved in products liability cases nationwide.
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