Medtronic Inc.’s Sprint Fidelis recall has caused many patients physical injury from having to undergo additional surgeries, receiving unnecessary shocks and even death. However, psychological injuries for patients with the Fidelis are also very real according to Neil Overholtz, a Florida attorney who represents Fidelis patients.

What is a psychological injury?

A psychological injury can be pain and suffering – or in this case, the stress associated with the possibility that a patient’s lead wire may shock them or even stop working altogether. Imagine wondering whether your surgically implanted cardiac lead wire – meant to keep you alive – has been pulled off the market because it’s defective. It’s a stress that most of us simply can’t imagine. Overholtz says that these psychological damages are very real injuries. He explained:

Proving these kinds of damages is often very difficult because juries are generally skeptical. However, it might not be as difficult with Medtronic cases. One of our clients was only 44 years old when he had a Medtronic Sprint Fidelis lead wire implanted. He is a boat salesman and avid sailor. Now he is concerned that he will not be able to continue to provide for his family. He has children and finds himself in an unbelievable situation. His doctor has told him that his defective lead cannot be replaced as the risk of complications makes the surgery far too complicated.

So now he's just worried. He doesn’t know what we're going to find out about how often these leads fail. I can tell you that it's one of the worst failure rates that we've seen. In the defibrillator litigation, the threshold was basically 1 in 10,000. If 1 in 10,000 failed, that was considered to be a really bad thing. That was when you would want to recall products. The Medtronic Fidelis failure rate is nearly 30 in 10,000, almost a 3% failure rate. It's really unbelievable and I believe that a psychological damage claim is very real.

If you or a loved one has a Medtronic Sprint Fidelis lead, contact a qualified attorney to discuss your situation. For a free, no-obligation consultation, please click here.