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Mark & Associates, P.C. Files Lawsuit Against Medtronic Inc. on behalf of Texas Man Implanted with Sprint Fidelis Leads on Two Separate Occasions


Patient Received 19 Unnecessary Shocks Requiring Implantation of Replacement Defibrillator and Second Recalled 6949 Lead

UNIONDALE, N.Y., Jan. 4, 2008 -- Mark & Associates, P.C., Gustafson Gluek PLLC, Neblett, Beard & Arsenault, Rheingold, Valet, Rheingold, Shkolnik & McCartney LLP & The Drakulich Firm announce they have filed a lawsuit on behalf of a Texas man against Medtronic Inc. (NYSE:MDT), Medtronic Puerto Rico, Inc., and Medtronic Puerto Rico Operations Co. The suit was filed in December 2007 in Hennepin County District Court, State of Minnesota, (docket #27-cv-07-26678). For more information on this suit and the recall of Medtronic Sprint Fidelis defibrillator leads, please visit and

About the Case

On May 13, 2005, the plaintiff was implanted with an ICD and a Medtronic Sprint Fidelis lead, model number 6949. On February 10, 2007, he experienced AICD failure and was taken to the emergency room. It was determined that he received 19 unnecessary shocks and that the Sprint Fidelis lead had fractured. The shocks depleted the battery in the AICD requiring the implantation of a new defibrillator.

The plaintiff was then transferred to the Little Rock VA Hospital for lead removal and replacement. On February 28, 2007, he underwent surgery at the Little Rock VA Hospital where doctors capped off the ends and left the fractured lead in place. The plaintiff was then implanted with a second Sprint Fidelis lead model number 694965, which is still in place today. It is possible that the plaintiff will need to have this lead replaced as well.

Medtronic Sprint Fidelis Leads

In 2004, Medtronic introduced and marketed Sprint Fidelis leads to replace the companyís popular Sprint Quattro leads. Medtronic claimed that the small size of the Sprint Fidelis leads would help improve passage into a patientís venous system for an easier implant. Shortly after Sprint Fidelis leads were introduced, reports of defects began to surface.

These defects were discussed in an article written by doctors at The Minneapolis Heart Institute based on a study of the incidence of lead failures in the Sprint Fidelis models compared to the Sprint Quattro models. The study compared the actuarial survival of 583 Sprint Fidelis Model 6949 leads implanted at the Minneapolis Heart Institute to the survival of 285 Sprint Quattro Model 6947 leads implanted at the Institute between November 2001 and March 2007.

The difference in survival between the Sprint Fidelis Model 6949 lead and the Sprint Quattro Secure Model 6947 lead was extremely significant. The failure rate for the Sprint Fidelis Model 6949 lead was ten times greater than the failure rate for the Sprint Quattro Secure Model 6947 lead.

On October 15, 2007, Medtronic recalled its Sprint Fidelis leads (models 6930, 6931, 6948 and 6949) from the worldwide market. When announcing the recall, the company cited internal data which showed the leads have a propensity to fracture, and were responsible for several deaths. Patients with these leads are encouraged to contact their physicians immediately if they have not done so already. Patients can request a free legal consultation by visiting

About Mark & Associates, P.C.

Mark & Associates, P.C. is a leading products liability and personal injury law firm with offices in Boston, Massachusetts and Long Island, New York. The firm aggressively represents victims of defective pharmaceuticals and medical devices, dangerous consumer products, bad faith insurance denials, toxic exposure and serious auto and common carrier accidents. Mark & Associates, P.C. and Neblett, Beard & Arsenault have evaluated more than 500 potential claims on behalf of consumers who have received Medtronicís recalled Sprint Fidelis leads. More information on Mark & Associates, P.C. is available at

CONTACT: Mark & Associates, P.C.
Jason Mark, Esq.



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