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by: Steve Fields294
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Medtronic Lead Recall Overview

On October 15, 2007, Medtronic, a Minnesota corporation, announced it was recalling its Sprint Fidelis brand of defibrillation leads. Medtronic said the recall was because of “the potential for lead fractures.” At that time, there were reports of at least five deaths associated with the defibrillator leads. The FDA certified the recall as “Class 1.” A Class 1 recall is the most serious type because it involves situations where there is a reasonable probability that the use of the product will cause death or serious injury.

What Do Defibrillators Do?

Defibrillators monitor heart rhythms. If they detect an unstable rhythm, they deliver an electric shock to the heart to shock the heart back to normal. This shock is approximately 750 volts, which is more than 100 times the shock delivered by a pacemaker. Defibrillators consist of two parts. The first is a computerized device that monitors heart rhythms and determines when to shock the heart. This devise is implanted under the skin near the patient’s shoulder. The second part of a defibrillator consists of “leads.”

What Do Leads Do?

Leads are wires that connect the defibrillator to the heart. They are threaded through veins to specific parts of the heart. The leads carry out two functions. First, they deliver information of an abnormal heart rhythm to the defibrillator. Second, if an abnormal heart rhythm is detected, they send a shock to the heart to stabilize it.

What Problems Occur?

“Fractures,” or breaks, in the leads can cause the defibrillator to deliver unnecessary shocks to the heart. Fractures can also fail to deliver a shock when one is needed. The following defibrillators have been recalled due to problems with the leads:

• Sprint Fidelis 6930
• Sprint Fidelis 6931
• Sprint Fidelis 6948
• Sprint Fidelis 6949

After lead fractures, some patients have died and many others have reported experiencing problems including unneeded shocks and jolts. Approximately 268,000 Sprint Fidelis leads were implanted worldwide.

How Do Patients Know If Their Leads are Defective and What Should They Do?

Patients should check their wallet card for the model numbers for 6930, 6931, 6948, and 6949. If you have one of these models, or are unsure, the FDA recommends contacting your doctor immediately. Although there is no way to test for a lead fracture, Medtronic and the FDA recommend patients have their defibrillator settings adjusted. This might increase the likelihood that a fracture will be detected before a patient is harmed. Medtronic and the FDA do not recommend having the leads removed because of risks associated with the removal surgery. Patients should discuss all options with their doctor to determine the proper procedure for them.

Medtronic Class Action Lawsuits?

Lawsuits against Medtronic for defective defibrillator leads are handled in what is referred to as multidistrict litigation, or “MDL.” The lawsuits are consolidated for the “discovery” phase and transferred to the federal court in Minnesota, which is where Medtronic is located. After the discovery stage, the cases are transferred back to the original court where they were filed. In other words, even though there could be tens of thousands of cases, they are handled individually.

About the Author

Steve Fields is author of this article on Medtronic Recall. Find more information about Medtronic Recall here.

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