|
Medtronic Inc. has stopped distributing Sprint Fidelis defibrillation leads because of the possibility that these leads could fracture in a small percentage of patients.
Although the leads continue to function properly in the vast majority of patients, if one does fracture, the defibrillator could deliver unnecessary shocks or not operate at all. Some deaths and major complications have occurred when the leads fractured.
The affected products are Sprint Fidelis Models 6930, 6931, 6948, and 6949. They are used with implantable cardioverter-defibrillators (ICD) or cardiac resynchronization therapy defibrillators (CRT-D).
Medtronic is advising physicians to stop implanting the leads and to return unused leads to the company. FDA and Medtronic are not recommending prophylactic removal of the leads in most patients, because the risk of removing the lead exceeds the small risk of a fracture.
In addition, the company recommends reprogramming the device to monitor the patient more effectively for potential problems, and to provide an audible alert if a lead does fracture.
Patients who have the Sprint Fidelis lead should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients should also recognize that a small number of Sprint Fidelis leads are used with defibrillators made by manufacturers other than Medtronic. If patients think they have a Sprint Fidelis lead, or if they do not know the model of their lead, they should contact their doctor. Additional Information: FDA MedWatch Safety Alert. Medtronic Sprint Fidelis Defibrillator Leads. October 16, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fidelis Medtronic, Inc. Important Information About the Sprint Fidelis® Defibrillator Lead. October 2007.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/linkwarning/linkwarning.cfm?link=http%3A%2F%2Fwww%2Emedtronic%2Ecom%2Ffidelis%2F
***********************************************************************************
In all personal injury cases, it is extremely important that measures be taken promptly to preserve evidence, investigate the accident or toxic exposure in question, and to enable physicians, attorneys, or other expert witnesses to thoroughly evaluate any injuries. If you or a loved one or friend is injured and may have a potential legal claim, call The Mulligan Law Firm now at 1-866-LAW-0001 (Extension 245). The initial consultation is free of charge, and if we agree to accept your case, we will work on a contingent fee basis, which means we get paid for our services only if there is a monetary award or recovery of funds. You may have a valid claim and be entitled to compensation for your injuries, but a lawsuit must be filed before the statute of limitations expires. Do not delay! If you delay, and the statute of limitations time period expires, you may lose all your rights to file any claim for compensation of any kind. If you need additional help, please fill out our form on this website or call us for help at 1-866-LAW-0001 (1-866-529-0001, Extension 245) or email us at
This e-mail address is being protected from spambots, you need JavaScript enabled to view it
.
A member of our firm will call you as soon as possible to help you determine the possibility of filing a potential claim.
For a free, no-obligation consultation with an experienced attorney regarding cases of personal injury and wrongful death, please submit our potential case intake form on this website for a free evaluation of your situation. We will respect the confidentiality of your information to the fullest extent. Form submissions are relayed to us through our highly secure servers.
If you prefer, you may contact us at (214) 219-9779 Extension 245 or (866) 529-0001, Extension 245.
The Mulligan Law Firm's affiliated attorneys represent clients throughout the United States in conjunction with local counsel licensed in other jurisdictions:
Alabama Alaska Arizona Arkansas
California Colorado Connecticut Delaware
Florida Georgia Hawaii Idaho
Illinois Indiana Iowa Kansas
Kentucky Louisiana Maine Maryland
Massachusetts Michigan Minnesota Mississippi
Missouri Montana Nebraska Nevada
New Hampshire New Jersey New Mexico New York
North Carolina North Dakota Ohio Oklahoma
Oregon Pennsylvania Rhode Island South Carolina
South Dakota Tennessee Texas Utah
Vermont Virginia Washington West Virginia
Wisconsin Wyoming
|
