|MEDTRONIC LEADS FREQUENTLY ASKED QUESTIONS
- What is a lead?
- What is a defibrillator?
- Which leads are being recalled?
- Why are the leads being recalled?
- What happens if a lead breaks?
- Has anyone been hurt?
- How does the recall work?
- How do I know if I have a recalled lead implanted?
- What should I do if I have an implanted recalled lead?
- What are my options if I have an implanted recalled lead?
- What are my legal rights?
Leads are thin electronic wires that connect an implanted medical device, such as a defibrillator, directly to the heart.
A defibrillator is a medical device that is implanted into the chest of a cardiac patient to monitor the heart rate and prevent cardiac arrest. Defibrillators detect irregular heartbeats and provide electrical shocks as needed to restore a normal heart rhythm. They keep the heart from going too fast. They are used for patients who are at risk of sudden cardiac arrest. The defibrillator is connected to the heart by leads.
There are two types of defibrillators affected by the lead recall: Implantable cardioverter-defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds).
Which leads are being recalled?
The following models of Medtronic leads are currently being recalled:
| Sprint Fidelis | 6930 |
| Sprint Fidelis | 6931 |
| Sprint Fidelis | 6948 |
| Sprint Fidelis | 6949 |
Why are the leads being recalled?
Medtronic is recalling the leads because they have discovered that they are prone to fracture. This means that the leads may break after they are implanted into a patient’s chest.
What happens if a lead breaks?
Since the leads connect the defibrillator device directly to the heart, a broken lead may create a life-threatening situation. The defibrillator may provide electrical shocks when the patient does not need them or it may not operate at all when the patient does need to be shocked.
Yes. Medtronic has “… identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor.” The FDA has stated that “… some deaths and major complications have occurred after the leads have fractured.”
Out of the 268,000 people who have the recalled leads implanted, less than 1% have broken so far.
Medtronic will no longer make or sell the specific models of leads that are being recalled. They are requesting that all unused leads be pulled from inventory and returned to the company. Medtronic is not recommending the surgical removal of any recalled leads already implanted into patients.
How do I know if I have a recalled lead implanted?
Every patient with an implanted defibrillator should have an identification card which specifies important information about the implanted device. The information may be on this card. If not, ask your doctor or call Medtronic at 1-800-551-5544, ext. 41835.
Remember that the recalled leads were only used with defibrillators, not with pacemakers. Not all Medtronic defibrillators use the recalled leads. And only certain models of Medtronic leads are being recalled. See the list of recalled models.
What should I do if I have an implanted recalled lead?
For medical advice, you should contact your doctor, especially if you have experienced multiple shocks, lightheadedness, fainting, or palpitations.
For legal advice, you should contact our offices for a free case evaluation by one of our experienced pharmaceutical attorneys.
What are my options if I have an implanted recalled lead?
a. Continue using the defective lead while monitoring for signs of a break.
Medtronic has advised doctors on how to adjust the defibrillator settings to more effectively monitor for potential breaks in the leads.
b. Surgically add a replacement lead without removing the defective lead.
In this surgery, a new lead is added and the defective lead is left in place, but is capped so that it will no longer be used.
c. Surgically remove the defective lead.
The FDA and Medtronic advice against the routine removal of the defective lead because in most patients, the risk of surgical removal is greater than the risk that the lead will break.
You should discuss the options with your doctor. You can also call Medtronic at 1-800-551-5544, extension 41835 for more information.
If you have a recalled lead implanted, you may be entitled to compensation.
The Law Offices of Howard L. Nations is a national pharmaceutical litigation firm representing people who have been injured by defective drugs and medical devices. Contact our offices for a free case evaluation by one of our experienced pharmaceutical attorneys.
The Nations Law Firm | A National Pharmaceutical Litigation Firm
4515 Yoakum Boulevard | Houston, TX 77006-5895 | Telephone: 713-807-8400 / Toll Free: 1-800-269-3050 | FAX: 713-807-8423
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