Medtronic Heart Lead Recall | Class Action Lawsuit
On October 15, 2007, Medtronic, Inc. announced that it was recalling its Sprint Fidelis defibrillation leads. Medtronic announced that the recall was due to “the potential for lead fractures.” At the time of the recall, there were reports of at least five deaths associated with the defibrillator leads. The Food and Drug Administration classified the recall as “Class 1,” which is the most serious type of recall and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death.
What is a Medtronic Defibrillator?
A defibrillator monitors heart rhythms. If it detects an unstable rhythm, it delivers an electric shock to the heart (approximately 750 volts, which is more than 100 times the shock delivered by a pacemaker) to shock the heart back to normal. A defibrillator consists of two parts. The first is a computerized device that monitors the heart rhythms and decides whether to shock the heart. This devise is implanted under the skin near the shoulder. The second part of a defibrillator is called “leads.”
What are Sprint Fidelis Leads?
Leads are wires that connect to the defibrillator. They are threaded through veins to specific parts of the heart. The leads perform two functions: (1) they deliver information of an abnormal heart rhythm to the defibrillator; and (2) send a shock to the heart when an abnormal rhythm is detected.
What is the Problem with Defective Leads?
Lead fractures, or breaks, can cause the defibrillator to deliver an unnecessary shock to the heart, or fail to deliver a shock when one is needed. Following lead fractures, some patients have died and many others have reported experiencing problems including unnecessary shocks and jolts. The following defibrillators have been recalled due to problems with the leads:
• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949
Approximately 268,000 Sprint Fidelis leads were implanted worldwide.
How Do I Know If My Medtronic Leads are Defective and What Do I do?
There is no way to test for a lead fracture. If you have a wallet card, check the model numbers for 6930, 6931, 6948, and 6949. If you have one of these models, or are unsure, the Food and Drug Administration recommends contacting your doctor immediately. For these models, Medtronic and the FDA recommend patients have their defibrillator settings adjusted, which may increase the likelihood that a fracture will be detected before a patient is harmed. Medtronic and the FDA recommends against having the leads removed because of removal risks. However, patients should discuss all options with their physicians.
Is there a Medtronic Class Action Lawsuit?
Lawsuits against Medtronic for defective leads are handled through what is called multidistrict litigation, or “MDL.” The lawsuits are pursued individually, but are consolidated for the “discovery” phase and transferred to the federal court in Minnesota, which is where Medtronic is located. After the discovery stage, the cases are transferred back to the original court where they were filed. This means that, although there could be tens of thousands of cases, they are handled individually.
If you or a loved one has been injured by a defective Medtronic defibrillator lead please contact us for a free consultation and case review. A Medtronic class action lead 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.
We are a law firm dedicated to helping those injured by Medtronic Sprint Fidelis Defibrillator Lead.
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U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
Some people who have been harmed by defective Medtronic leads have filed lawsuits against the manufacturer. But, before filing a Medtronic lead lawsuit, there are several things that you should know.
Which product is defective?
Medtronic Sprint Fidelis defibrillator leads were more prone to fracturing than previous generation models of leads. Defibrillators are implanted heart devices that [...]
Medtronic manufactured a type of heart defibrillator lead that had defective wires. The defective wires were “leads,” which connected the defibrillator to the heart. The leads would fracture, or break, on numerous defibrillators. The Medtronic lead fracture was deadly in some patients.
Which defibrillators were defective?
The Medtronic lead fracture would occur in the Medtronic Sprint Fidelis [...]
Medtronic has been has been involved in litigation for defective Sprint Fidelis heart defibrillator leads. These Medtronics lawsuits were initiated because the “leads,” which are wires that connect the defibrillator device to the heart, could break, causing serious injury, and even death in some patients.
How many defective leads were produced?
More than 268,000 Medtronic Sprint Fidelis [...]
If you are seeking Medtronic lawsuit dismissed 2010 information and news about the recall related to your internal cardioverter defibrillator, we can provide the necessary background, facts and resources you need.
Medtronic Defibrillator
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Patients across the country continue to file Medtronic Sprint Fidelis lawsuit claims spurred by lead recall of the Sprint Fidelis wires. As patients face long-term side effects from the faulty defibrillator wires, they seek compensation from the company they believe knew of the wire problems long before the recall was issued.
A defibrillator is a life-saving [...]
