Medtronic Cable Extraction Dangers

 
Category: 
Defective Medical Devices

When Medtronic withdrew their Sprint Fidelis heart defibrillator cable in 2007, it opened up another way for patients to become injured or die. Because thousands of people who had the Sprint Fidelis inserted as a life saving device now have to have it removed over the next several years in a risky surgery, there will be more victims of this defective medical device.

The defibrillator, or lead, is supposed to jolt the heart to keep its rhythm normal. However, the cable sometimes cracks, which keeps the jolt from a heart whose rhythm has begun to act erratically, or continuously shocks the patients with random discharges. If the defibrillator is connected to a pacemaker, then it may interfere with the way the pacemaker is supposed to work.

The Medtronic heart defibrillator cable debacle has not affected everyone who was implanted with one. For the 45 months the product was implanted, Medtronic estimates it failed only five percent of the time. However, more patients whose cables have not malfunctioned want them removed as a preventative measure. It is estimated that nearly a quarter million people have had Sprint Fidelis heart defibrillators implanted around the world. And herein lays the problem.

Over time, about 15 years, defibrillator cables wear out. But because the recall came only three years after Medtronic put them on the market, these cables are still very new. Sometimes the cables have a tendency to become overgrown with tissue after they’ve been in the body for a period of time. This causes the cables to become stuck inside veins that lead to the heart. For experienced cardiologists, removing them from these locations is a challenge. Still, there are less experienced surgeons attempting to remove the cables. As a result, there have been four deaths due to the patient bleeding out. Over the next several years, more victims seeking removal of the defective defibrillator cable may wind up bleeding to death in the operating room.

Though Medtronic has provided some patients with directions on extraction, it has not done so publicly. It recently compiled a list of centers that have experience with extracting the Sprint Fidelis, but has also only agreed to provide the FDA with data from ten of these centers in order to win approval for a new heart cable. Medtronic has also supplied replacement cables, but the cost is being borne by Medicare and private insurers at a cost of $15,000 to $20,000.

Medtronic has also been shielded from lawsuits thanks to the Supreme Court’s preemption decision last year. In short, as long as the FDA has approved the product, victims of defective products may not sue the manufacturer. However, several Congressmen are rumored to be working to overturn this decision.

Whatever happens with those who have Sprint Fidelis heart defibrillator cables and Medtronic’s advice that extraction should be the last thing tried, it is ultimately up to doctors to expose patients to this risk.