Much has been posted about the dangers associated with the defective Medtronic Sprint Fidelis Leads. Just recently it was revealed that there are more deaths associated with this faulty lead wire than Medtronic had previously reported. Lawsuits for injuries due to malfunctioning of the Sprint Fidelis Lead wires have been dismissed on the basis of preemption – a simple meaning being that FDA approval prevents lawsuits under state tort laws.
Now to add insult to injury, the New York Times has printed a very alarming article about the difficulty in removing these lead wires. Not only have people died as a result of a malfunction of the wires, now people are dying as a result of doctors trying to extract the wires. The procedure is quite complicated and there are a few doctors who have the necessary experience to perform it. The deaths have resulted from damage to a vein or the heart during the risky procedure causing extensive bleeding. Even the physicians who have the most experience with explanting these wires are saying that the procedure presents many challenges to them.
It’s really unfair that patients and their doctors have been put in this precarious position. And it’s even more unfair that Medtronic might not be held accountable for their actions.