Medtronic Sprint Fidelis Leads Recalled

USA — Medtronic has suspended sales of theSprint Fidelis family of defibrillatorleads because of the potential for leadfractures, reports of at least five patientdeaths and other serious, life-threatening complications. Matthews & Associatesare actively handling these cases.

The Sprint Fidelis family of defibrillatorleads have been recalled withmodel numbers 6930, 6931, 6948,6949.The lead may also have been used toconnect defibrillators manufactured byother companies such as Guidant,Boston Scientific, and St. Jude.

The FDA recommends that patientswith the Sprint Fidelis lead implantedcontact their physician immediately, especiallyif they have experienced multipleshocks, lightheadedness, fainting, orpalpitations.

“Fractures in the Sprint Fidelis leadsmay lead to audible alerts, inappropriateshocks and the loss of output,"Medtronic said. Medtronic first notifiedphysicians in March 2007 about thefracture rate at that time and the propermethod for implantation. Additional data on adverse events accumulatedsince then has prompted the recall.

The Sprint Fidelis leads were especiallyuseful for some because the narrowdiameter made them easier tothread into veins, but the narrownessalso made them more prone to fracture.