Medtronic Sprint Fidelis Wire Lead for Defibrillators

What is the Sprint Fidelis Wire Lead?

Sprint Fidelis leads are thin wires that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. Both devices work by monitoring heart rhythms and delivering an electrical shock to restore heart function when life-threating heart rhythms occur.

Medtronic Sprint Fidelis leads are being recalled because the electronic wires are prone to fracture in some patients, which would cause the defibrillator to deliver unnecessary shock or not to operate at all.

Sprint Fidelis Wire Defibrillator Lead Failure

There are still thousands of patients who have Medtronic's Sprint Fidelis leads left wondering if they should leave the wire lead in place and hope it does not fail or whether to have it extracted, sometimes at their own expense. Medtronic is limiting its contribution to wire lead removals to $800.00 for a procedure that can cost $12,500.00, and insurance companies appear to be dealing with coverage on a case-by-case basis.

Legal Compensation for Harm Caused by Sprint Fidelis Malfunction

Legal compensation claims for serious injury or death arising from a Medtronic heart lead wire failure should be made by filing a separate lawsuit for each plaintiff as opposed to being made part of a large class action. Statutes of limitations for personal injury and wrongful death cases vary from state to state.

Sprint Fidelis Heart Lead Wire Failure Class Actions

We believe that people who suffered an adverse medical event following a breakage or failure of a Medtronic Sprint Fidelis heart lead wire are better served when an individual lawsuit is filed on their behalf. A serious injury or death case should not be filed as part of any Sprint Fidelis class action together with the claims of many other people who may have had different injuries, or no injury, caused by their lead wire malfunction.

A March 2007 "Dear Doctor" Letter About Sprint Fidelis Heart Leads / Defibrillator Wires Was Little Noticed At The Time

The March 2007 "Dear Doctor" letter from Medtronic about its Sprint Fidelis lead wire would tell us what the company knew about the Sprint Fidelis problems back then. At that time of the October 2007 FDA recall, however, the letter was not available on the Medtronic website, nor on the FDA website.

Medtronic Fidelis Sprint Lead Failures: Did The FDA Wait Too Long To Issue Its October 2007 Recall

U.S. health regulators received reports of 1,194 patient injuries in the first 10 months of 2007, compared with 296 in the same period in 2006, the consumer group Public Citizen said, citing U.S. Food and Drug Administration data. The jump in numbers of patient injuries, and an even greater increase in reports of inappropriate patient shock, was apparent in the first few months of 2007, the group said.

US FDA: Class 1 Recall: Medtronic Inc. Sprint Fidelis® Defibrillator Leads

October 15, 2007 alert on FDA website.

US FDA Statement on Medtronic's Voluntary Market Suspension of Their Sprint Fidelis Defibrillator Leads

Medtronic announced it was voluntarily suspending distribution of its Sprint Fidelis defibrillation leads because a small number of fractures have been detected. As a result of Medtronic's action, no more Sprint Fidelis leads will be sold or manufactured and any remaining product should be pulled from inventory and returned to the company. Patients who are implanted with this lead are encouraged to contact their physicians for further information.

US FDA Questions and Answers about Sprint Fidelis Defibrillator Leads

October 15, 2007 letter from Medtronic to patients

Medtronic warns patients that the possibility of fracturing or breaking exists in Sprint Fidelis wire leads and urges them to see their healthcare professionals for guidance.

March 21, 2007 Sprint Fidelis Dear Doctor Letter

Medtronic has received reports from a limited number of implanting physicians indicating they have experienced higher than expected conductor fracture rates in their centers with Sprint Fidelis leads.

Medtronic Press Release announcing suspension of Sprint Fidelis defibrillator leads

Medtronic voluntarily suspended worldwide distribution of the Sprint Fidelis family of defibrillation leads because of the potential for lead fractures. In addition, the company recommends against new implants of the leads (Sprint Fidelis Models: 6930, 6931, 6948, 6949).

What is an Implantable Cardioverter Defibrillator?

From the National Heart, Lung, and Blood Institute.

Medtronic Sprint Fidelis Lead Wire Case Evaluation

Drug Injury Watch: Medtronic Sprint Fidelis Lead News and Commentary