Should You Have Your Defective Medtronic Defibrillator Lead Replaced?

Jennifer Moore

Contributor

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On October 15, Medtronic acknowledged that its Fidelis lead for defibrillators was fracturing and recalled the product. Now, heart patients must decide whether to undergo surgery and have the faulty lead and defibrillator removed and replaced. The operation may last approximately 90 minutes depending upon the individual patient. Medtronic has only offered to pay $800 toward the surgery and provide a replacement lead.

You should consult your physician immediately to determine whether you are a candidate for surgery.

The defaulty defibrillator lead has been linked to at least five deaths and numerous cases of unnecessary shocks. The default in the product could prevent the defibrillator from firing when needed.

The lead, called the Fidelis, is a spaghetti-thin plastic tube enclosing electrical wires and sensors. The risks of the patient's operation, besides the possibility for infection, included potential perforation of his heart and the veins in his chest. There was also a slight danger of damaging the heart valve through which the lead had been threaded in 2005, when doctors had screwed the tip into muscle in the bottom of the right ventricle of his heart.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.