LAWSUITS NEWS & LEGAL INFORMATION
Medtronic Sprint Fidelis Leads
Medtronic, Inc. has voluntarily suspended sales of its Sprint Fidelis defibrillation leads--a component of Medtronic's implantable cardioverter defibrillators (ICDs) that link the heart to the ICD. Personal injury lawsuits are now being filed against Medtronic alleging the company is responsible for manufacturing and marketing defective defibrillators.
Sales stopped after the Sprint Fidelis leads were linked to five patient deaths. The electronic leads can fracture, causing the defibrillator to misread heart rhythms. This can cause the defibrillator to either deliver unnecessary shocks or not deliver shocks when necessary. In addition to the deaths, serious complications have also occurred as a result of lead fracture.
Medtronic estimates that more than two percent of patients fitted with Sprint Fidelis leads will suffer a lead fracture within 30 months of lead implantation. Medtronic will cover the cost of the faulty lead and contribute up to $800 to pay for medical costs not covered by insurance. However, so far the company will not pay for the cost of replacing a lead that has not malfunctioned, meaning that patients who are concerned about a potentially faulty lead will have to pay for the surgery on their own.
There are reportedly around 268,000 leads implanted in patients in the US and around the world. So far, the company and the FDA have only recommended that patients see their doctors to have their ICDs reprogrammed. The reprogramming would better monitor for the potential of lead fracturing. They have not recommended having the leads replaced because such surgery is considered risky, more so even than defibrillator replacement surgery.
Any patients who are not sure if Sprint Fidelis leads were used with their defibrillator should contact a healthcare professional. It is possible that Sprint Fidelis leads were used with defibrillators that were not made by Medtronic.
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Defective Sprint Fidelis Leads
Medtronic estimates that more than two percent of patients fitted with Sprint Fidelis leads will suffer a lead fracture within 30 months of lead implantation. Medtronic will cover the cost of the faulty lead and contribute up to $800 to pay for medical costs not covered by insurance. However, so far the company will not pay for the cost of replacing a lead that has not malfunctioned, meaning that patients who are concerned about a potentially faulty lead will have to pay for the surgery on their own.
There are reportedly around 268,000 leads implanted in patients in the US and around the world. So far, the company and the FDA have only recommended that patients see their doctors to have their ICDs reprogrammed. The reprogramming would better monitor for the potential of lead fracturing. They have not recommended having the leads replaced because such surgery is considered risky, more so even than defibrillator replacement surgery.
Any patients who are not sure if Sprint Fidelis leads were used with their defibrillator should contact a healthcare professional. It is possible that Sprint Fidelis leads were used with defibrillators that were not made by Medtronic.
Medtronic Sprint Fidelis Legal Help
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SPRINT FIDELIS LEGAL ARTICLES AND INTERVIEWS
Medtronic Sprint Fidelis: Four Have Died During Extractions
Failure Rate of Medtronic Sprint Fidelis Lead Could Be Higher
Medtronic Sprint Fidelis Leads Sparked "Extreme Anxiety"
April 8, 2009
Two years after Medtronic stopped selling the vilified Sprint Fidelis lead, there is a growing concern as to its continued viability—and while Medtronic and the medical community in general recommend not replacing working leads unless they fail, some doctors are doing just that. READ MORE
Failure Rate of Medtronic Sprint Fidelis Lead Could Be Higher
February 24, 2009
Patients with the Medtronic Fidelis Sprint lead, a medical device that connects to the heart and was expected to be effective in 95 percent of patients in spite of a recall two years ago, may be worse off than first thought. A new study suggests that three years after implantation the Sprint Fidelis lead is only expected to remain functional in 88 percent of patients. READ MORE
Medtronic Sprint Fidelis Leads Sparked "Extreme Anxiety"
October 17, 2008
Patients who have been affected by the 2007 Medtronic Sprint Fidelis lead recall are contacting lawyers to determine whether or not they have a claim against Medtronic. While some people have actually been harmed by fractured Sprint Fidelis leads, others say they constantly live with the fear that their defibrillator will not work as promised, a potentially fatal problem. READ MORE
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READER COMMENTS
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I was then told that I would need a defibrillator installed and that I could never play any contact sports ever again. In which put me in a bind becaise I was making about $450 per game. What a financial blow that was. I want to say about 3 months later my device shot off while I was working out about 4 times which scared the living hell out of me. I went to the hospital and the Medtronic rep said that whoever set up my device, set my device to low for a person of my age group he fixed the issue. Then I want to say about another 2 months or so it went off again about 4 times while I was working out again. I went to see the Medtronic rep and he couldn't figure out why my device went off again he reset it and that was it.
As time went on I then recieved a letter late 2004 from Medtronic to contact my Dr about certain defects regarding my device. I spoke with my Dr early 2005 and he said that I need to schedule a replacement surgery pronto. This procedure he said is life threatening.
What these mega companies and these defense lawyers are not getting is that being told that your device is being recalled is something that is very depressing and uneasy to handle because this product is suppose to save my life. I look at my situation and thought I can’t let this get me down. And I moved on.
I want to say about a couple months after my replacement surgery which took a couple of months to heal and is a life threatening procedure. I saw a news report stating that Medtronic knew about the defective devices and still put them out there for profit. And then was paying doctors kickbacks to help promote these defective products.
Receiving this info put me in a state of depression. I looked at the situation like if I can’t trust my own doctor who can I trust. Medtronic made billions off the people by selling the people defective devices.
Medtronic argued that the federal Safe Medical Devices Act of 1990 preempted state law claims related to its products. “Medtronic thought that within one year, this litigation would be history because of preemption. Not the case. Rosenbaum ruled that the plaintiffs had raised triable issues of fact as to whether Medtronic had actual knowledge of the defect and hid that evidence from the FDA.
In his ruling, Rosenbaum wrote, “It defies logic, and flies in the face of Congress’s decision to impose a regime strictly regulating medical device manufacturers, to think Congress intended the result Medtronic advocates.â€
Know with all this info on the table, it is an insult to the American public for these mega defense lawyers and mega corporations to think that they can do whatever they want to the people to gain profits. And it is another insult to know that the Bush administration is backing these corupt businesses up. I’m wondering if Medtronic cut the Bush administration a check to join forces with them.
This issue is one of the biggest decisions the Supreme Court will ever have to face. Even with Judge Rosenbaum defending the people. Medtronic has equiped themselves with probably the best defense team put together. But with the edvidence against them its going to be a challenge for Medtronic to overcome these sticky charges. I am not looking for a big payday here I just want justice to be issued and Medtronic to be made the example of corupt business practises. To me Medtronic is worse than the well known Enron company.
To me this reminds me of the biblical story of David and Goliath. May God be with all the victims.
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I have consent pain in my neck where they cut me open 6 six times. Physical therapy did not work for the pain. Where the battery was I also have a lot of pain.
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