Lead Extraction

Medtronic Defibrillator Lead Extraction Surgery

Medtronic defibrillator lead models 6930, 6931, 6948 and 6949 were recalled due to the potential for the wires to fracture. Patients that have experienced a lead fracture are faced with an additional complex surgery that can involve substantial risk. Leads that have fractured are very difficult to remove because of how the leads are placed during the original surgery and the fact that after implantation scar tissue forms around the leads. An alternative to removing the defective lead is to thread a second wire into the vein that connects it to the heart and cap off the original fractured lead. A new lead is then implanted and the capped lead is no longer useable.

What is a Sprint Fidelis Lead?

A lead is a thin, flexible wire that travels through a vein and delivers energy to the heart from an implantable cardioverter defibrillator (ICD) - special devices implanted under the skin that help a patient’s heart beat in a regular rhythm. Two, or sometimes, three leads are used to connect the patient’s heart to the defibrillator.

What is Lead Extraction?

When the leads are initially inserted through the veins of the chest and connected to the heart, they can be easily removed. However, eventually scar tissue forms around the leads. Lead extraction is the surgical removal of one or more leads from the inside of the heart and veins using special techniques that safely release the lead from the surrounding scar tissue.

How is Lead Extraction Surgery Performed?

The patient receives general anesthesia before the surgery. The extraction is performed by hooking a special wire onto the inside of the lead, or by placing a snare through a vein to grasp the outside of the lead. The surgeon then pushes a plastic tube with a laser over the lead to help separate it from the scar tissue in the veins and the heart. The plastic tubes, or sheaths, break the scar tissue to prevent tearing the veins or heart.

Lead Extraction Sites

Lead extraction can be performed at two different sites:

• Subclavian vein - most commonly used. An incision is made in the upper chest over the subclavian vein.
• Femoral vein - used when the subclavian procedure cannot be performed. A small puncture is made in the groin over the femoral vein.

The surgeon will numb the site. A sheath (hollow plastic tube) is placed in the vein and guided to the tip of the lead. The sheath helps to free the lead from any scar tissue that has developed. The lead is then removed by pulling it out through the sheath.

A laser or special electrosurgical sheath is used to deliver energy to remove scar tissue from around the lead that is holding it in place where it is attached to a vein or heart tissue. A new lead will then be implanted and connected to the heart.

Fractured Lead

Lead Extraction Sheath

If you have a lead fracture and are scheduled for surgery feel free to contact us and we can talk to you about your upcoming procedure and legal issues related to the defective lead and surgery. We offer a free no-obligation consultation for all Medtronic Sprint Fidelis patients who have questions or concerns regarding lead replacement surgery. Please call Toll Free at 1-888-343-5375 or fill out our short online contact form and an attorney will contact you to answer any of your questions.