Medtronic Defibrillator Defective Sprint Fidelis Lead Recalled
Recall Oct. 15, 2007
Sprint Fidelis Models
6930, 6931, 6948, 6949
Irregular heartbeat Fibrillation
Extreme Chest Pain
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 leads 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.
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