When Medtronic, Inc. recalled electronic wires attached to heart defibrillators due to the risk of serious heath complications and death a couple of years ago, many patients were left wondering the best course of action. If the faulty wire is removed from the hearth defibrillator, the heart and veins could be damaged. However, if the wire is kept in place, it could cause unnecessary shock or may not operate at all.
The recall involved the Sprint Fidelis Leads, which are thin wires that connect an implantable defibrillator directly to the heart, after it was discovered that the devices have the potential for lead fractures. Defibrillators are life-saving devices for many people, as they monitor heart rhythms. These devices deliver an electrical shock or rapid pacing to restore normal rhythm when irregular or life-threatening heartbeats are detected. Four Sprint Fidelis Models were included in the recall: 6930, 6931, 6948 and 6949. According to the U.S. Food and Drug Administration, the announcement to suspend distribution of this product constitutes a medical device recall.
Medtronic stated that the risk of a defective wire attached to the heart defibrillator is low. It has been estimated 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. However, that means that 4,000 to 5,000 people could be affected by the defective Sprint Fidelis Leads. There have already been numerous deaths and serious injuries where a fracture in a Sprint Fidelis Lead may have been a contributing factor.
Patients who have the Sprint Fidelis Leads can remove the defective lead, but there is a high risk of health complications. If the lead has been in place for a long time, scar tissue may have grown around it after implantation. Removing the old lead can cause bleeding from torn veins and can damage the heart muscle. Only an experienced doctor and hospital should perform the procedure. Another option is to insert a new lead into the vein, attach it to the heart and then put a cap on the old Sprint Fidelis lead.
The side effects from a defective lead can be painful and life-threatening. If you have suffered from a Sprint Fidelis lead, you may be entitled to compensation for your injuries. Contact an experienced Florida mass tort lawyer at the Law Offices of Lilly, O’Toole & Brown, LLP at (863) 683-1111 to review your case.