Fractures in the Sprint Fidelis leads can cause a defibrillator to deliver repeated, painful shocks to a patient’s heart. Approximately one-third of the 1,600 patients who have experienced malfunction or injury from their Sprint Fidelis leads have suffered unnecessary shocks to the heart due to fractured lead wires.

Many doctors say that only patients whose defibrillator leads have already fractured will need to have them replaced. However, a number of patients who have a thickening of the heart muscles or other conditions that could place them at an increased risk of Sprint Fidelis side effects have chosen to have the lead wires remove voluntarily.

But in spite of the Sprint Fidelis recall and the $12,000-plus cost of replacing the defibrillator leads, Medtronic has said that it will contribute only $800 to each individual for surgeries to replace the lead wires, no matter how great the patient’s risk of problems with their Sprint Fidelis leads.

Some doctors are also concerned that patients whose Sprint Fidelis leads are used with both a defibrillator and pacemaker may also be at an increased risk of serious side effects in the event that the lead wire fractures. Fractures that affect a pacemaker’s ability to control the pace of a patient’s heartbeat are placed in even more danger than those who only have a defibrillator. Studies have shown that about 80% who receive a defibrillator implant will never need to use the device to restore normal heart rhythm.