On October 15, 2007, the Food and Drug Administration issued a Class I Recall involving the Medtronic, Inc., Sprint Fidelis® Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949. This recall specifically relates to those leads manufactured from September 2004 through October 15, 2007. This action does not affect Medtronic pacemaker patients.
In March 2007, Medtronic reported two primary locations where chronic conductor fractures have occurred on Sprint Fidelis leads. Those are at: the distal portion of the lead, affecting the ring electrode and near the anchoring sleeve tie-down, affecting the helix tip electrode, and occasionally the high voltage conductor. High voltage conductor fractures could result in the ability to deliver defibrillation therapy. Anode or cathode conductor fractures may present increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. The potential for defibrillation lead fracture to result in or contribute to inappropriate shocks or death has been reported. As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide. Based on current information regarding the 268,000 implanted leads, Medtronic has identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. We are currently investigating claims involving the particular recalled leads. Ted Meadows and Russ Abney are the primary lawyers handling Medtronic Heart Device Lead Wire cases for the Section.
