Medtronic Sprint Fidelis Leads: Doctors, Patients Face Tough ChoicesApr 8, 2009 | Parker Waichman LLP
The procedure to remove one of Medtronic Inc.'s defective Sprint Fidelis defibrillator leads is dangerous and complicated. According to a report in The New York Times, because of the risks involved, patients implanted with a Sprint Fidelis lead and their doctors often face difficult choices.
A lead is a wire that connects an implantable defibrillator to the heart. If a lead breaks, the defibrillator can emit a massive and painful shock. And in the worse case scenario, the fractured lead can prevent a defibrillator from sending a necessary, lifesaving shock to the heart.
The Sprint Fidelis lead was removed from the market in October 2007, following reports of 5 deaths due to lead fractures. As we reported last month, Medtronic recently sent a letter to doctors informing them that the faulty wires were a “possible or likely contributing factor” in as many as 13 deaths. Four of the deaths occurred when doctors tried to remove defective Sprint Fidelis leads from patients.
Before the recall, Sprint Fidelis leads had been implanted with 90% of Medtronic’s defibrillators. According to the Wall Street Journal, 268,000 defective Sprint Fidelis leads had been implanted worldwide, and about 235,000 people still had these leads in their chests when the recall was issued. According to The New York Times, around 150,000 people are still implanted with a Sprint Fidelis lead.
Replacing a lead is not an easy procedure, as the invasive surgery can cause the tissue of the blood vessels and heart to tear. In fact, replacing a defibrillator lead is so risky that patients with Sprint Fidelis leads were told to leave the defective components in place unless they fracture.
But some patients and doctors are uncomfortable with that advice, The New York Times said. Some surgeons are choosing to take out the leads pre-emptively in patients who depend on their defibrillators to stay alive. Others have begun removing the leads when a patient needs a new defibrillator.
Regardless of when it is done, removing a Sprint Fidelis lead is a risky procedure. One doctor told The New York Times that the four patients who died having a lead removed could just be "the tip of the iceberg." A lead should be removed by a skilled surgeon, and at a medical center were many such procedures have been performed, the Times said.
That's also the guidance Medtronic has given to patients who need to have a Sprint Fidelis extracted. But according to the Times, while the company recently supplied the Food & Drug Administration with a list of 10 medical centers that have experience with lead removals, it has so far declined to make the list public.
In addition to being difficult, the procedure to extract a Sprint Fidelis lead is expensive. The operation alone can cost as much as $20,000 dollars, the Times said. But so far, Medtronic has only agreed to cover the cost of replacement wires.
Unfortunately, the Sprint Fidelis problem is only going to get worse. According to The New York Times, Medtronic expects that thousands of people will need to have Sprint Fidelis leads replaced over the next several years.