Medtronic Sprint Fidelis Defibrillator Leads May Cause Injury or Death

• Fractured Medtronic Sprint Fidelis lead wire has malfunctioned in hundreds of patients.
• Five patient deaths have been linked to the defect.
• New units recalled as of October 14, 2007.
  

On this Page:

• Fractured Sprint Fidelis leads cause dangerous malfunction
• Watch for symptoms of a broken Sprint Fidelis lead wire
• Dangerous and expensive replacement surgery may be necessary
• Contact your doctor
• Contact an injury lawyer at Kershaw Cutter & Ratinoff

Fractured lead causes dangerous malfunction

A defibrillator is a device that is surgically implanted in the heart to monitor heart rhythm and to “shock” faltering hearts back to normal rhythm.  Medtronic has advised doctors and patients to stop using its defective Sprint Fidelis electrical “lead” — a wire that connects the heart to a defibrillator — because this wire has a tendency to fracture.  A fractured wire can cause two serious and frightening problems:

• The faulty lead causes the device to deliver painful electrical jolts.
• The faulty lead can cause the device to fail to provide a life-saving “shock” when a patient’s heart needs one.

Medtronic, the largest manufacturer of implanted heart devices in the United States, is urging all of the approximately 268,000 patients worldwide (178,000 in the U.S) with Sprint Fidelis leads, to immediately see their doctors to find out if the wire has fractured.  Medtronic’s own estimate is that some 4000 to 5000 patients will experience a lead fracture within 30 months of implantation.  The Sprint Fidelis wire has been used with Medtronic defibrillators since 2004.

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Watch for symptoms of a broken Sprint Fidelis leads

The FDA advises patients who have had the Sprint Fidelis lead implanted to contact their doctors, especially if they have experienced the following symptoms:

• multiple shocks
• lightheadedness
• fainting
• heart palpitations

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Dangerous and expensive replacement surgery may be necessary

Experts say that replacing the leads on a defibrillator can be even more dangerous than replacing the entire device, according to an article in the New York Times.  Medtronic has offered to pay for a small fraction of the cost of this replacement surgery only if the lead wires are malfunctioning.  Most of the expense of replacement surgery will be the responsibility medical insurance and individual patients.

Medtronic has not offered to pay victims for lost wages, pain and suffering caused by cardiac surgery and hospitalization, or any other expenses caused by its dangerous and defective product.

Further, Medtronic has refused to pay to replace functioning leads that fearful patients may wish to replace to avoid problems in the future.

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Contact your doctor

If you or someone you know has had a Medtronic Defibrillator with Sprint Fidelis® leads implanted, a medical doctor should be consulted immediately to review the safety of the device.

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Contact the injury attorneys of Kershaw, Cutter & Ratinoff

The personal injury attorneys of Kershaw, Cutter and Ratinoff have handled hundreds of cases involving defective medical devices.  Recently KCR has litigated and settled numerous cases involving the 2005 recall of defective Guidant® defibrillators and pacemakers.  We have the specific knowledge and experience needed to help our injured clients obtain fair compensation from companies such as Medtronic.

If you or a loved one has received an implanted Medtronic defibrillator with Sprint Fidelis leads, you may be entitled to full payment by Medtronic for any additional surgery or medical treatment, as well as other damages including lost wages and pain and suffering.

Please click here for a free case evaluation.

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