Medtronic

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If you or a loved one has suffered serious injury or death due to a faulty heart device, you may want to speak with a lawyer who can assist you with making important personal and legal decisions, please contact us for a free case evaluation.

Medtronic Sprint Fidelis Defibrillator Lead

As of October 2007, the U.S. Food and Drug Administration (FDA) issued a statement to announce Medtronic’s voluntary recall of their Sprint Fidelis defibrillator leads. Medtronic is a medical technology company. The leads link the human heart to an implantable defibrillator. Sprint Fidelis leads may have been used with Medtronic defibrillators as well as defibrillators manufactured by Guidant, Boston Scientific and St. Jude.

Approximately 268,000 Sprint Fidelis leads have been implanted since they were introduced in the fall of 2004. To date, 2.3% of the leads have malfunctioned, or fractured, since the introduction of the device. Lead fractures may cause patients to receive unnecessary shocks, sometimes, massive shock. Other patients may not receive the shock when it is needed.

So far, there have been five deaths related to the recalled leads.

Medtronic’s Sprint Fidelis – Recalled model numbers are: 6930, 6931, 6948, 6949. The recall does not affect Medtronic pacemaker patients.

According to the FDA, “Medtronic, its Independent Physician Quality Panel, and Bruce Lindsay, M.D., Professor of Medicine, Director of Cardiac Electrophysiology, Washington University School of Medicine and President of the Heart Rhythm Society (HRS), do not recommend that patients seek prophylactic replacement of Sprint Fidelis leads, as the risks of removal or insertion of another lead exceed the small risk to patients of a lead fracture. Medtronic has provided patient management recommendations that should reduce risks in the affected population and recommends that patients with questions consult their physicians.”

If you or a loved one has been implanted with a Medtronic Sprint Fidelis lead and you have experienced a problem, you may want to speak with an attorney, today, regarding a potential lawsuit. A lawyer familiar with new developments in the investigation of these leads may be able to help you make important personal and legal decisions. Give us a call at 800-992-6878 or please CLICK HERE for a free consultation.

Helpful Links:

FDA statement on Medtronic’s recall of their Sprint Fidelis Defibrillator Leads
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01724.html
Patient letter from Medtronic – Regarding Sprint Fidelis Lead Performance
http://www.medtronic.com/fidelis/patient-letter.html

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