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Editor: Marc Jay Bern
Profession: Defective Medical Device Lawyer

Category: About Sprint Fidelis Defibrillator Lead Lines

Below we have some common questions and answers about Sprint Fidelis defibrillator leads to help address questions and concerns patients may have following the defibrillator recall, Medtronic announced, in October.

How do I know if my Sprint Fidels Lead Defibrillator was recalled?
Many patients were given a patient card that identifies any implanted medical devices you have. If you don't have a patient card and you are unsure about your devices, you should contact your doctor and request your medical records.

Why did Medtronic Recall Sprint Fidelis Leads?
The devices were recalled because of potential lead fractures. The wires are prone to fractures in a small number of patients, which can cause the defibrillator to shock the patient unexpectedly or to not work at all. Five deaths and other serious injuries have been reported in which a fracture in the Sprint Fidelis leads may have been a contributing factor.

How is Medtronic Handling the Recall?
Medtronic announced that they are voluntarily suspending distribution of the Sprint Fidelis defibrillator leads, worldwide. The (4) Sprint Fidelis models included are: 6930, 6931, 6948, and 6949.

How Many People have a Recalled Sprint Fidelis Defibrillator?
There have been approximately 268,000 Sprint Fidelis leads implanted in patients worldwide, since October 4, 2007, including 172,000 Sprint Fidelis leads implanted in patients in the United States.

Also Read: What Should Patients do if they have a Sprint Fidelis Defibrillator Lead?