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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: About Sprint Fidelis Defibrillator Lead Lines

The FDA, device makers and doctors were at the ICD Lead Performance Conference, in Boston, to discuss implantable cardioverter defibrillators (ICDs) .

Following the fallout from Medtronic's Sprint Fidelis defibrillator wire recall, in October, two of the main topics include the wires failure to jolt a patient's heart when needed and the device malfunctionging and sending inappropriate shocks to the patients heart.

In April, a study estimated that 40% of defibrillator leads will fail within eight years of implantion, significantly higher than previously thought.

A lot of discussion at the meeting involves the inadequacy of voluntary reports by doctors and current lab tests to provide a true measure of lead breakage. The issue rose to prominence in October, when Medtronic recalled its popular Fidelis lead on evidence it was breaking at unacceptable rates.

For more information on this subject matter, please visit our section on Medical Devices & Implants.