6931 Medtronic Sprint Fidelis lead recall class action lawsuit

In October 2007, the patients and doctors were informed of the Medtronic recall of the Sprint Fidelis lead Model 6931. It was found that the Medtronic 6931 lead along with lead Models 6930, 6948 and 6949 were at risk of developing fractures in particular locations. As of October 2007, Medtronic was aware of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures (approximately 90%) have occurred in the anode or cathode conductors.

The Medtronic recall applies only to the leads and not implanted defibrillation or pacemaker devices. If a patient has one of the implanted leads their Patient ID card should contain one of the following four sets of numbers: 6930, 6931, 6948, 6949. These numbers may be part of a longer string of numbers on the ID card. Pacemakers help keep the heart from going too slowly compared to defibrillators which keep the heart from going too fast. The Medtronic Sprint Fidelis recall does not include Medtronic devices that are pacemakers. Patients who have Medtronic ICDs or CRT-Ds without Sprint Fidelis leads are also not affected by the Medtronic recall.

The 6931 Medtronic lead is a thin wire that connects an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. Defibrillators monitor a patient’s heart rhythms. They are surgically implanted for patients at high risk of sudden cardiac arrest. An electrical shock is transmitted or rapid pacing to restore normal rhythm when irregular heartbeats are detected. Defibrillators keep the heart from going too fast.

A total of 268,000 Sprint Fidelis leads were implanted in patients throughout the world, with 172,000 leads implanted in the United States. As of January 2007, approximately 5,387 Medtronic Sprint Fidelis Model 6931 leads had been implanted. Implantable cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy-Defibrillators (CRT-Ds) are used to treat abnormal heart rhythms in patients which can cause the heart to suddenly stop. ICDs and CRT-Ds shock the heart back into normal rhythm by delivering a pulse of energy through an electronic wire (lead) that is connected to the heart.

Patients who have either received a Medtronic recall letter or have one of the lead recall Models listed on their patient ID card are urged to contact their doctor’s office with any questions about their leads. Doctors are encourage to analyze the risks versus benefits of either leaving the lead implanted along with careful monitoring or implanting a different lead model. Extraction of leads involves serious risks to the patient. Medtronic’s Independent Physician Quality Panel recommends that if one of the recalled leads (Medtronic lead 6931) requires removal, the surgery be performed by a doctor with extensive extraction experience.

It has been reported that doctors with limited extraction experience may significantly increase the risk of complications during extraction. Some of the reported complications of lead removal include: lead breakage and migration; avulsion of veins, myocardium of the tricuspid valve; tears of the myocardium or veins; hemothorax, tamponade, perforation, emergency cardiothoracic surgery, pulmonary emboli, and death. Lead extraction carries risks that need to be considered and discussed between the patient and their doctor. Published literature suggests major complications (death or surgical intervention) from lead extraction range from 1.4 – 7.3%.