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Medtronic Lead (ICD) Recall Attorneys
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Questions about Medtronic Sprint Fidelis Defibrillator Lead Recall
What are Sprint Fidelis Leads?
Sprint Fidelis is the brand name given by Medtronic to a series of models of cardiac electrodes that connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart. These are devices designed to protect patients from life-threatening heart rhythms, including elevated, depressed, or irregular heartbeats.
How do implanted defibrillators work?
Defibrillators monitor heart rhythms, and deliver electric shocks when appropriate to stimulate the heart to beat with a regular rhythm. The goal is to protect patients at risk of sudden cardiac arrest.
Is Medtronic announcing a recall?
Technically, no. On October 15, 2007, Medtronic announced that it was "voluntarily suspending" sales and distribution of the lead model numbers 6930, 6931, 6948, and 6949. However, since the company has asked doctors to cease implantations and return the product, the FDA considers the action equivalent to a recall. Obviously, Medtronic is seeking to avoid the negative financial implications of using the word "recall."
How do I know if I have been implanted with the recalled leads?
You may have a patient card that identifies the specific maker and model number of both your leads and your ICD or CRT-D. If you cannot find or do not have a patient card, contact your physician to find out whether you are effected by the recall.
Why are the leads being recalled?
The leads are being recalled because they break in a small number of cases. The broken leads can cause the defibrillator to give a warning, or they can lead to painful shocks. Finally, they might also lead to the defibrillator failing to function when needed, which means a risk of cardiac arrest and death.
What should I do if I have been implanted with a recalled lead?
If you have been implanted with a lead, you should contact your physician, especially if you have experienced shocks, lightheadedness, fainting, or palpitations.
You should not seek removal of the leads. It is recommended that you closely monitor the leads for signs of fracture, and you may seek to add a replacement lead which can carry the shock to your heart instead of the Sprint Fidelis lead. The unused lead remains in your chest, but is capped.
You should also call or email us at Burg-Simpson to consult about the possible legal recourses that remain open to you if you or someone you love as suffered as a result of a Sprint Fidelis lead fracture.
Read more about the "Medtronic Sprint Fidelis Defibrillator Lead Recall".
