News from the FDA Concerning Medtronic Sprint Fidelis Leads
On August 28, 2008, I posted a story about Medtronic’s defective Sprint Fidelis defibrillator leads on InjuryBoard.com.
The story mentioned the difficulty surgeons would encounter in removing the defective Medtronic leads. In the meanwhile, the FDA and Medtronic have been cooperating to arrive at a workable interim solution to enable doctors to track down potential lead fracture. Today, the FDA approved Medtronic software update that gives doctors the capability of monitoring and identifying potential defibrillator lead fractures on a 24 hour basis. The ability to determine when and where lead fractures are occurring will benefit patients who may require crucial medical intervention.