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Medtronic Defibrillator Defective Sprint Fidelis Lead

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On October 15, 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators.   According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt.   This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal.   At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

The Sprint Fidelis lead have been used in implantable Medtronic defibrillators since 2004, and most patients who received the devices since then have the faulty leads.   Sprint Fidelis leads were used only in cardiac defibrillators -- or complex devices with defibrillation capacity -- and not in conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

Medtronic Defibrillator Lead Recall
Medtronic decided to suspend sales of the Sprint Fidelis lead after a company review of 30 months of data showed that the defibrillator lead had a continuing fracture problem.   According to the company’s own estimate, approximately 2.3%, or 4,000 to 5,000 people with a Sprint Fidelis lead will experience fracture within 30 months of having a Medtronic defibrillator implanted.   Those patients whose Sprint Fidelis lead fractures will require a dangerous surgical procedure to have the wire replaced.

For the unlucky patients who experience a fracture of a Sprint Fidelis lead, three things can happen.  If they are fortunate, the implantable defibrillator will beep, alerting the patient to seek immediate medical attention.  Or, the fracture can create a massive electrical shock that causes the patient extreme and sudden chest pain.  But most disturbingly, the fracture of a Sprint Fidelis lead can deplete the Medtronic defibrillator’s battery.  If this happens, the Medtronic defibrillator can fail to deliver a necessary, life-saving shock to the heart. 

In addition to suspending sales of the Sprint Fidelis lead, Medtronic also recalled all unused leads on the market.  The company also advised patients with Medtronic implantable defibrillators that may have used the defective Sprint Fidelis lead to see their doctors.  Replacing leads on an implantable defibrillator is far more risky than replacing the device itself, so the company was not advising that patients with a Sprint Fidelis lead have those replaced.  Rather, it urged physicians to reprogram the defibrillators to minimize the problem.  Medtronic said the new programming would allow the implantable defibrillators to better monitor and warn of problems with the Sprint Fidelis leads.

Medtronic Defibrillator Charging Problem
On April 16, 2004 Medtronic announced that it was recalling two heart defibrillators because they have been linked to at least four deaths and one injury. Medtronic said that some of these defibrillators have failed to charge properly which can result in the late delivery or no delivery of cardiac shock therapy.

The charging problem involves the Medtronic Micro Jewel II Model 7223Cx and the Medtronic GEM DR Model 7271 implanted cardioverter-defibrillators. Medtronic said that most of these devices were implanted in 1997 and 1998. About 1,800 are thought to be still in use.

These devices are used to shock the heart into normal rhythm after patients suffer irregular heartbeat or fibrillation, which are rapid, life-threatening arrhythmia's, originating in the lower chambers of the heart. The defibrillators are implanted surgically in the chest. When a cardiac arrhythmia occurs, the capacitor is charged and the device delivers the appropriate shock.

Medtronic said that with the suspect defibrillators, the capacitors may take longer than normal to charge near the end of the battery service life and could cause a delay in delivery or no delivery of shock therapy. A delay or no delivery of shock therapy can be life threatening.

Medtronic Defibrillator Lawsuit Lawyers
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