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On October 15, 2007 the Medtronic Corporation recalled models of Medtronic Sprint Fidelis Defibrillator Leads. Defibrillators are used to regulate a person's heartbeat. The device can sense an abnormal heart rhythm and then deliver an electronic shock to reset the heart to a normal beat. A defibrillation system consists of a device implanted near the shoulder with one or more leads connecting the device to the heart.
The Following Medtronic Sprint Fidelis Leads were recalled:
- Sprint Fidelis 6930
- Sprint Fidelis 6931
- Sprint Fidelis 6948
- Sprint Fidelis 6949
These were manufactured between September 2004 and October 2007.
Patients with a Medtronic heart defibrillator have been advised by the company to consult their doctors about a "potentially" faulty wire attached to the devices, causing potential panic among patients.
The lead, when operating properly, is supposed to assist the defibrillator in delivering a shock to the heart when it goes into a rhythm known as "ventricular fibrillation."
A lead is a wire that is attached to an implantable defibrillator and is connected to a patient's artery. When the defibrillator detects that a patient needs to receive a shock, the defibrillator issues a charge which travels through the lead and shocks the artery thus making the heart beat correctly. Medtronic has recalled these certain types of leads because the outer coating on these leads has been known to crack. If a Medtronic lead has cracked and not functioning, the defibrillator cannot deliver the proper charge to the artery. It is estimated that there are approximately 268,000 recalled leads that have already been implanted in patients.
"These electronic wires are prone to fracture," says the Food and Drug Administration (FDA) in a recently-released statement, and this fracture "can cause the defibrillator to deliver unnecessary shocks or not operate at all. Based on our initial review of reported adverse events, some deaths and major complications have occurred after the leads have fractured."
Every individual who had a heart defibrillator implanted at one point was given a device identification card that will indicate the model and serial number of the defibrillator that was implanted as well as the model and serial number of each lead that was also implanted.
A fracture in the defibrillator lead can cause a defibrillator to deliver unnecessary shocks to the heart or not operate at all. Medtronic has begun asking doctors to stop implanting the leads and return all unused leads to Medtronic.
According to the FDA, "Neither FDA, Medtronic, nor representative of the Heart Rhythm Society recommend the routine surgical removal of a fractured lead because removal carries risks. Instead, physicians should weigh the benefits and risks of either continuing to use the lead with careful monitoring or capping the lead so it is no longer usable and implanting a different model.
On October 22, 2007 Medtronic sent out a letter to all individuals who may have the recalled device.
Free Legal Consultation
If you or a loved one has an implanted defibrillator, you may have valuable legal rights. To protect these rights, contact Keel O'Malley Tunstall, L.L.P. today by completing the submission form on the left side of this page or by calling 1-888-KEEL-LAW (1-888-533-5529).
Remember, because of statute of limitations, you have a limited time to seek compensation. Contact Keel O'Malley Tunstall, L.L.P. so that we may assist you in protecting your legal rights.
The devices are being recalled because of the potential for lead fractures. These electronic wires are prone to fracture in a small number of patients. This could cause the defibrillator to deliver unnecessary shock or to not operate at all. Some deaths and other serious injuries have been reported in which a fracture in a Sprint Fidelis lead may have been a possible or likely contributing factor.
How many people have had this device implanted?
As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide, including 172,000 Sprint Fidelis leads implanted in the United States.
On October 22, 2007 Medtronic sent out a letter to all individuals who may have the recalled device.
We would be happy to discuss your legal rights with
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is NO CHARGE for the initial consultation. If you
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our firm look forward to helping you with your products liability claim, call Keel O'Malley Tunstall L.L.P. at
(252) 823-2266 or toll free at 888 - KEEL - LAW, or submit an online
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Our Firm is also handling Medtronic Neuromodulation ScnchroMed Implantable Infusion Pump recalls.
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