USA — Medtronic has suspended sales of the Sprint Fidelis family of defibrillator leads because of the potential for lead fractures, reports of at least five patient deaths and other serious, life-threatening
complications. Matthews & Associates are actively handling these cases.

The Sprint Fidelis family of defibrillator leads have been recalled with model numbers 6930, 6931, 6948,6949. The lead may also have been used to connect defibrillators manufactured by other companies such as Guidant, Boston Scientific, and St. Jude.

The FDA recommends that patients with the Sprint Fidelis lead implanted contact their physician immediately, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations.

“Fractures in the Sprint Fidelis leads may lead to audible alerts, inappropriate shocks and the loss of output," Medtronic said. Medtronic first notified physicians in March 2007 about the fracture rate at that time and the proper method for implantation. Additional
data on adverse events accumulated since then has prompted the recall.

The Sprint Fidelis leads were especially useful for some because the narrow diameter made them easier to thread into veins, but the narrowness also made them more prone to fracture.