There was a massive recall a couple of years ago involving Medtronic, Inc.’s Sprint Fidelis Leads. It was found that these thin wires that connect an implantable defibrillator directly to the heart had the potential for lead fractures. Lead fractures can increase the risk of serious heart complications and death.
Heart defibrillators monitor heart rhythms and deliver an electronic shock or rapid pacing to restore normal rhythm when irregular or life-threatening heartbeats are detected.
After this recall, many patients were faced with a dilemma. If they decided to have the defective wire removed from the defibrillator, their heart and veins could be damaged, especially if the lead was in place for a long time and grew scar tissue. On the other hand, if they kept the lead in place, it could cause unnecessary shock or may not operate at all. The side effects of a defective lead in the heart defibrillator can be painful and life-threatening.
Medtronic stated that only 2.3 percent of the 235,000 patients who are believed to have the defective wire will experience a lead fracture within 30 months of implantation. Even though that percentage seems low, it means that 4,000 to 5,000 patients may be affected by the defective Sprint Fidelis Lead.
If you have suffered as a result of the defective lead by Medtronic, contact the Law Offices of Lilly, O’Toole & Brown, LLP at (863) 683-1111 for legal advice.