Medtronic Sprint Fidelis Leads
Medtronic Inc. manufactures Sprint Fidelis Leads. Leads are thin wires of cardiac electrodes that connect from the Implantable Cardioverter-Defibrillator (ICD) to the heart. ICDs are devices that are implanted underneath the patient's skin and monitor the patient's heart rhythm, shocking the heart when there is a life-threatening heart rhythm. ICDs are implanted for patients who may suffer sudden cardiac arrest. For a detailed discussion on the purpose and function of ICDs, see the ICD Article.
Medtronic's Recall
On October 15, 2007, Medtronic suspended the worldwide distribution of its Sprint Fidelis defibrillation leads, manufactured from September 2004 through October 15, 2007, and included the following models:
- Model 6930
- Model 6931
- Model 6948
- Model 6949
Medtronic advised physicians to stop implanting these leads and to return leads that were unused back to the company. Medtronic also advised that patients who were implanted with these leads, or did not know the model of their lead, to see their doctors immediately for more information.
One way that a patient can determine if he or she has been implanted with a Sprint Fidelis lead is to look at the patient card, which indicates the devices that have been implanted. If there is any doubt regarding what type of lead you have, you should contact your doctor.
Reason for Recall
The Sprint Fidelis Leads were recalled because there have been some fractures of the leads, or breakage of the leads. When the leads fracture, this can cause the defibrillator to deliver shocks unnecessarily or not function at all. Deaths and other serious injuries have been reported in association with the breakage of the leads.
Steps for Patients to Take
If you are a patient who had a Sprint Fidelis lead implanted, the FDA recommends that patients contact their doctor, particularly if they have experienced palpitations, multiple shocks, lightheadedness, or fainting.
Additionally, the FDA does not recommend having leads that work removed, because the risks associated with removing a device outweigh the risk of having lead fractures. The patient can be monitored while still using the lead, so as to detect any possible lead fractures. Alternatively, a replacement lead can be added. For a FDA Questions and Answers page regarding Medtronics Recall of Sprint Fidelis Cardiac Leads, click on this link: http://www.fda.gov/consumer/updates/medtronic101507.html.
Having a fractured lead can be life threatening. According to the FDA, as many as 268,000 Sprint Fidelis leads were implanted in patients worldwide as of October 4, 2007. Specifically, 172,000 Sprint Fidelis leads were implanted in people in the United States.
If you or someone you know has had a Sprint Fidelis Lead implanted that has been affected by the recall, and you have been injured as a result, contact Anderson Law Offices to protect your rights and interests.
