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On October 15, 2007 the FDA issued a Class 1 recall on four different models of Medtronic pacemaker leads (Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death). Medtronic Sprint Fidelis recalled model numbers 6930, 6931, 6948 and 6949 manufactured from September 2004 through October 15, 2007. The leads are thin wires that connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) directly to the heart. ICDs and CRT-Ds are devices that are used to treat abnormal heart rhythms that can cause the heart to stop suddenly. These leads are being recalled because a fractures have been detected. When the lead breaks (fractures), it may cause shocks or result in a loss of therapy, such as pacing or shocking.
The Sprint Fidelis® lead has been implanted in approximately 268,000 people worldwide. The defibrillator can misread information from the heart and administer a shock when one is not needed. The defibrillator also could stop working if it loses its connection to the heart.
How do I know if I have a Sprint Fidelis lead?
You may have a patient card that identifies the implanted devices you have. If you have any uncertainty about your devices, you should contact your physician.
What should patients do if they have had a Sprint Fidelis lead implanted?
Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting or palpitations. Patients who have had the Sprint Fidelis lead implanted should contact their physician, especially if they have experienced multiple shocks, lightheadedness, fainting, or palpitations. Patients should not routinely seek removal of the device. The risks of removal in most patients exceed the small risk of lead fractures. Therefore, it is generally recommended to leave functioning leads in place. There are two alternatives to removing the lead. One is to continue using the lead while monitoring closely for signs of fracture. A second is to surgically add a replacement lead. Adding a replacement lead does not require removing the Sprint Fidelis lead. If the Sprint Fidelis is left in a patient without being used, it must be “capped”, which means covering the tip with a small plastic insulation.
Is there anything legally I can do if I have one of these leads implanted?
Our lawfirm is currently accepting claims for patients who have been effected by this recall. You should contact us as soon as possible if you would like to have your case reviewed by an attorney that can determine if your case is one that would have merit. You should be compensated for the risk that these leads have put you in with your health. Call our firm to learn more.