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.
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.”
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.
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.
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.
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.
Medtronic Recall Lawsuit
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.
Patients subject to the Sprint Fidelis recall continue to suffer from a Medtronic lead failure leading to a surgery to replace the defective lead. The Multidistrict Medtronics lawsuit is currently under appeal and lawyers representing victims are continuing to fight for the right to bring a claim for compensation.
If you have been diagnosed with an [...]
In January 2009 the United States District Court ruled the Sprint Fidelis Medtronic Lawsuit Dismissed. This ruling is currently under appeal and attorneys representing patients and families affected by the Medtronic recall continue to fight for their rights. The Medtronics recall involves only the Sprint Fidelis lead and not the implanted heart device.
The defibrillator lead [...]
The Medtronic lead lawsuit Multidistrict litigation continue even though there have been setbacks and we continue to push for the Medical Device Safety Act legislation which will help protect patients with medical devices. The Sprint Fidelis recall failure rate of defibrillator leads continues to leave heart patients in the difficult position of not knowing if [...]
It is estimated there are 150,000 heart patients throughout the United States affected by the Medtronic lead recall who have a recalled defibrillator lead wire and are at risk of a lead fracture. Medtronic lawsuits continue to be filed on behalf of patients who have suffered a lead fracture. The Medtronic Sprint Fidelis leads were [...]
Patients continue to suffer from a Medtronic Sprint Fidelis lead fracture following the 2007 Medtronic recall of defibrillator leads. If you or a loved one has suffered from fractured leads please contact us today for a free consultation and information how we can help.
What is a Defibrillator?
We’ve seen them used on the TV hospital programs, [...]