Medtronic Heart Defibrillator Wires Present a Tricky Choice for Patients and Physicians; Remove, or Leave in Place and Hope for the Best?

Hundreds of thousands of heart patients who have Medtronic Sprint Fidelis heart defibrillator wires implanted in their chests to correct irregular heartbeats and prevent fatal heart attacks face tough questions about how best to proceed.

The wires, also called leads, connect defibrillators and pacemakers to a chamber of the heart to deliver an electrical shock when needed to correct heart arrhythmia. They were recalled in 2007 after five patients died and studies later found the wires had a tendency to break and deliver repeated shocks to the heart when not needed or fail to work when necessary.

According to Medtronic, the wires work properly 95 percent of the time and that only five percent of Sprint Fidelis patients have experienced problems. But that’s not enough for some patients, who are asking surgeons to surgically remove the wires out of fear they may be defective and fail to work properly.

As many as 250,000 people were implanted with Medtronic Sprint Fidelis leads from 2004 to 2007. An estimated 150,000 people in the United States still have the wires in their bodies, so thousands of patients must make a difficult decision in the coming years: Leave the wires in place and hope they work as designed, or go under the knife to try and have the device removed and possibly suffer death or serious injury in the process.

Serious Problems With Removing Wires

Removing Medtronic heart defibrillator wires is not a simple or fail-safe procedure, which makes deciding between extracting the wires and leaving them in place that much more difficult.

At least four patients have already died during surgeries to remove the wires, and some experts fear many more will die if the procedures are not performed by qualified, experienced surgeons. Since the procedures to remove Medtronic wires are not widely offered at medical centers, patients wanting to have them extracted may have difficulty finding a qualified surgeon to perform the operation.

In some cases, surgeons have had difficulty removing the wires and found the devices entrapped in tissue or inside veins or the heart itself, experts said. Pulling the wires from those areas can lead to deadly bleeding and other life-threatening complications.

Medtronic Says Removal is a ‘Last Resort’

For its part, Medtronic advises Sprint Fidelis patients to seek experience surgeons if they choose to undergo extraction surgery and recently provided the Food and Drug Administration with information of medical centers the company considers qualified to perform extraction procedures.

However, the company has said extraction of the leads should only be done as a last resort.

“Medtronic believes that a patient’s physician is in the best position to make decisions related to patient care, including the most appropriate lead extraction center,” the company recently said.

There is no clear, best option for handling potentially defective Medtronic heart defibrillator wires, which is frustrating for patients and surgeons alike. When a vital organ such as the heart is involved, the idea of leaving in place a device that has a 95% success rate is hardly cause to breathe easy. One failure of the device could be deadly.

Therefore, Medtronic patients must proceed with caution and be sure that they are receiving qualified, experienced medical advice about how to handle their situation. The decision on whether to undergo extraction surgery or play the odds and leave the Medtronic Sprint Fidelis wires in place is not one to be taken lightly, for sure.

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