Medtronic Sprint Fidelis Patients Unsure of What to Do

Miami, FLIn what may be the ultimate case of being stuck between a rock and a hard place, patients with implanted Medtronic Sprint Fidelis Leads face a difficult choice between keeping their leads implanted and potentially having the leads malfunction or undergoing risky surgery to have the leads removed. Each option carries its own risks, neither of them entirely preferable, which has patients very concerned about what they should do.

The first option, the one that doctors are recommending, is to leave leads that are not fractured in place and change the settings on the leads. The reason for doing so is because surgery to take the leads out is quite risky. However, leaving the leads in place exposes the patient to a risk of the Medtronic Sprint Fidelis Leads fracturing and causing the patient's defibrillator to not work properly. A non-functioning defibrillator means that a patient could either receive unnecessary shocks or not receive shocks when needed, both of which are life-threatening situations.

Patients with the leads left in place also find that their day-to-day lives are deeply affected. Many say that they are concerned that increased activity may cause the leads to fracture, so they have cut back on their activity levels. Younger patients who have the leads implanted are concerned that, because of their age and activity level, they have a higher risk of the leads fracturing. Still, doctors are advising that they leave the leads in and monitor the situation.

The second option is surgery to remove the leads. However, the surgery is risky because of the scar tissue that can form around the leads. Patients are at a risk of developing infections or bleeding problems. The surgery is also expensive and it is not guaranteed that insurance will cover the costs, especially if the leads being removed have not yet fractured. Still, having the leads taken out may give patients peace of mind, knowing that they do not have to worry about one day receiving a life-threatening and completely unnecessary series of shocks.

Patients with the Medtronic Sprint Fidelis Leads implanted are understandably worried about their devices. Imagine living day-to-day knowing that at any time a device inside you could malfunction, giving you a very serious shock to your heart. The shocks these devices provide are not tiny shocks—they are very powerful, very intense shocks, designed to be strong enough to restore a regular rhythm to your heart. Patients who have survived receiving unnecessary shocks say that the shocks are incredibly painful.

Lawsuits have now been filed against Medtronic Inc., alleging the company manufactured products that were prone to fracturing and did not notify the public quickly enough about risks associated with the Sprint Fidelis Leads. Not all lawsuits are being filed by people with fractured leads: some are being filed by people whose lives have been affected by the potential of having a Sprint Fidelis Lead fracture. At least one lawsuit is seeking medical monitoring and future medical expenses for patients in California who are affected by the faulty leads. Other lawsuits are also being filed against Medtronic. As time passes and more people experience the shock of fractured leads, more lawsuits are likely to be filed.