Sprint Fidelis 6949 Defibrillator Leads | Medtronic Recall Lawsuit

If you or someone you know has received a Sprint Fidelis defibrillator lead 6949 you may have important legal rights. Many patients have experienced a lead fracture which can cause painful and sometimes life-threatening shocks to the heart or alternatively not provide a shock when needed. We are currently representing patients who have a defective Medtronic 6949 lead in filing individual Medtronic recall lawsuits.

Following the death of five patients Medtronic removed its Sprint Fidelis 6949 lead along with models: 6930, 6931 and 6948. A lead fracture in the defibrillator wire can cause serious problems by either sending an unnecessary jolt to the heart or not operating at all.

Medtronic 6949 Lead

U.S. Market Release September 2004
Serial Number Prefix LFJ
Type and/or Fixation Transvenous, Vent, Defib and Pace/ Sense, Screw-in
Polarity True Bipolar / Two Coils
Steroid Yes
Estimated U.S. Implants 188,200
Estimated U.S. Active 157,900

Fields Law Firm is a Minneapolis, Minnesota based law firm that is working with patients affected by the Medtronic recall throughout the United States.

We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and an attorney will contact you to answer any of your questions.

Medtronic Sprint Fidelis 6949 Lawsuit Class Action Recall Updates | Attorney Lawyer

The Minneapolis Heart Institute conducted a study of the Medtronic Sprint Fidelis 6949 lead and determined that the lead had a greater failure rate compared to the Quattro lead. In October 2007 Medtronic announced a recall of Sprint Fidelis lead 6949 along with leads 6948, 6930 and 6931.

Medtronic Lead Failure

Minneapolis Heart Institute Foundation Study

Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead.

Hauser RG, Kallinen LM, Almquist AK, Gornick CC, Katsiyiannis WT.

BACKGROUND: We have observed a higher than expected rate of Sprint Fidelis model 6949 lead failures in our practice.

OBJECTIVE: The aim of this study was to assess the performance of small-diameter Sprint Fidelis high-voltage ICD leads.

METHODS: The actuarial survival of Sprint Fidelis model 6949 leads implanted at our center was compared with that of the Sprint Quattro Secure model 6947. The United States Food and Drug Administration Manufacturers and User Facility Device Experience (MAUDE) database was searched for Sprint Fidelis models.

RESULTS: The survival of 583 Sprint Fidelis 6949 leads implanted at our center between September 2004 and February 2007 was significantly less than 285 Sprint Quattro Secure model 6947 leads implanted by us between November 2001 and February 2007 (P = .005). Six patients presented with Sprint Fidelis lead failure 4-23 months after implant. Five of the six patients experienced multiple inappropriate shocks associated with pace-sense conductor and coil fractures; the sixth patient had a fixation mechanism failure. The MAUDE search rendered reports for 679 Sprint Fidelis leads. The most frequent complaints or observations were inappropriate shocks (33%), high impedance (33%), and fracture (35%). Of 125 leads analyzed by the manufacturer, 62 involved fracture of the pace-sense conductor or coil and the high-voltage (defibrillation) conductor.

CONCLUSIONS: The Sprint Fidelis high-voltage lead appears to be prone to early failure. Its use should be limited until the failure mechanism is identified and corrected. Patients should be evaluated quarterly, and automatic lead test features should be enabled. While more data are needed, routine prophylactic replacement of intact, normally functioning Sprint Fidelis leads does not appear justified. PMID: 17599673 [PubMed - indexed for MEDLINE]

Reprinted courtesy of PubMed.gov, a service of the U. S. National Library of Medicine and the National Institutes of Health

If you or a loved one has questions regarding the Medtronic Sprint Fidelis 6949 lead recall please contact us and a Sprint Fidelis lawsuit attorney can help answer your questions. We offer a free, confidential no-obligation consultation to individuals and families affected by the Medtronic recall.

Medtronic lead recall 6949 Sprint Fidelis lawsuit

On October 15, 2007, Medtronic informed patients with Sprint Fidelis lead Model 6949 that their defibrillation lead was recalled. The Medtronic recall also affected patients with lead Models 6930, 6931 and 6948. Patients can identify which Medtronic lead they have by referring to their Patient ID card (wallet card) which will contain the model of their implanted lead. If a patient is unsure about which lead they have implanted they should consult with their physician.

A total of 268,000 Sprint Fidelis leads were implanted worldwide, with 172,000 leads implanted in the United States. As of January 2007, approximately 144,311 Medtronic Sprint Fidelis Model 6949 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.

ICDs consist of a generator, a processor and a lead. The lead works to conduct the electrical impulses between the heart and the ICD. Low voltage pacing therapy to treat slow heart rhythms is provided through pace-sense electrodes. High voltage defibrillation shocks are delivered through high voltage conductors.

Medtronic’s Sprint Fidelis leads were introduced in 2004 as a replacement for the Sprint Quattro Secure Lead Model 6947 (referred to as “Quattro leads”). The Sprint Fidelis leads were marketed as being smaller and more effective for patients with implantable cardiac defibrillators (ICDs).

By October 2007, Medtronic had notice of at least 665 chronic fractures in returned Sprint Fidelis leads. The majority of these fractures are in the Model 6949 Medtronic lead. It has been argued that Medtronic was aware that their Sprint Fidelis leads survival rate was unacceptable when compared to industry failure rates. Where a lead breaks, or “fractures”, the lead may send false signals which can cause the defibrillator to deliver inappropriate shocks or in the alternative shocks may not be delivered when needed. There is currently no test to predict which leads will fracture and the FDA is encouraging patients to seek follow-up care with their doctor to discuss options. It is not recommended that patients automatically have a fractured lead removed due to the risks involved with a surgical removal.

There are two main locations on the recalled Medtronic leads where fractures have occurred:

1. The distal portion of the lead which affects the anode (ring electrode) and;
2. Near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor.

Physicians are urged 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. 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.

As recently as May 2008, Medtronic has continued to maintain that routine monitoring is the preferred option for patients rather than lead removal due to the risks involved with extraction of the lead.

If you or a loved one has been injured by a defective 6949 Medtronic lead wire please contact us for a free consultation and case review. A Medtronic recall attorney can go over your legal rights and options and evaluate any potential claims you may have. You may be entitled to compensation and we can help.