Medtronic Issues another Safety Warning on Sprint Fidelis Leads in their Internal Defibrillators The stock for Medtronic, a heart device firm, dropped again yesterday by 11% when the company released another statement warning patient’s that the wires that connect the implantable defibrillators are breaking too often. After linking five deaths to the breaks in wires, Medtronic is telling doctors to discontinue use of the Sprint Fidelis wires when installing the internal defibrillators.
While a success rate of any heart defibrillator less than 100% is unacceptable, Medtronic and the U.S. Food and Drug Administration estimate that the wiring failure has occurred in less than 1% of the devices. With more than 268,000 of the defibrillators having already been implanted, faulty wiring in 1% of the devices totals to a worrisome nearly 2,700 potential unsafe defibrillators. As a result, Medtronic defibrillator lawsuits are beginning to show up throughout the country.
Although Medtronic has not referred to this announcement as a recall, the FDA has, and while neither group is recommending removing the devices if no other problems have been detected, both are erring on the side of caution and advising patients to have theirs checked out by their doctor. Patients with Medtronic defibrillators who are unsure whether or not they have a Spring Fidelis lead can contact Medtronic Patient Services at (800)-551-5544, ext. 41835, or go to www.medtronic.com/fidelis.
If you have been injured as a result of a Medtronic defibrillator defect, a Medtronic Lawsuit attorney of Williams Kherkher can help you decide on what, if any, legal action to take. Contact Williams Kherkher and schedule a free initial consultation by calling (866) 950-9000.
1 response so far ↓
1 JB // Oct 17, 2007 at 10:47 pm
There is a lot of interesting information out there about the medtronic sprint fidelis lead recall. I see that lawsuits have already been filed and would expect many more to be filed. These leads seem to be clearly defective and the failure rate is significant. There is more information on the fda website but it seems that the full extent of the problems with the medtronic defibrillator leads is not yet known. One thing we do know is that faulty leads can result in serious problems for the patient if they malfunction.
Medtronic has had other lawsuits filed against them in the past. These defective defibrillator leads will likley be another serious legal issue for the company as they face the prospect of verdicts against them.
Another big issue being discussed is whether patients should have the sprint fidelis defibrillator leads replaced or explanted. This is something people should discuss with their doctor.
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