Medtronic Sprint Fidelis Defibrillator Leads

The Sprint Fidelis Lead, like all leads used with implantable defibrillators (ICDs), is a special electrical wire that goes from the ICD to the heart. The lead allows the ICD to monitor the heart rhythm, and also carries a defibrillator shock from the ICD to the heart if a dangerous arrhythmia should occur. If the lead should fail, the ICD might not be able to detect or treat such an arrhythmia and/or a filling lead could trigger painful inappropriate shocks from the ICD.

On October 15, 2007 the FDA recalled Medtronic Inc. Sprint Fidelis Defibrillator Leads, model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. The reason being a number of fractures that have been detected. When a lead breaks (fractures), it may cause inappropriate shocks or result in a loss of therapy, such as pacing or shocking. Two days later, Medtronic announced that is was suspending all sales of Sprint Fidelis Lead models 6930, 6931, 6948 and 6949, because of the potential for the defibrillator lead fractures and which may have contributed to at least 5 deaths and numerous reports of unnecessary shocks in patients with the recalled Medtronic Leads.

At least 235,000 patients have been implanted the Medtronic Leads since 2004. They are connected to defibrillators made by Medtronic or by another defibrillator manufacturer such as Guidant or St. Jude, for which Medtronic supplied the lead. According to Medtronic, 4,000 to 5,000 people with a Sprint Fidelis Leads will experience a fracture within 30 months of having a Medtronic defibrillator implanted. Patients whose Medtronic Sprint Fidelis Lead fractures may require a risky surgical procedure to have the wire replaced.

If you or someone you know has an implanted defibrillator that uses a recalled Medtronic Sprint Fidelis Lead, please contact Goggins & Associates so that we may assist you in winning your case.