Medtronic Sprint Fidelis Leads: No Easy Answers

Miami, FLPatients who have had Medtronic Sprint Fidelis Leads implanted are starting to realize that when it comes to what they should do about the leads, there are no easy answers. This is especially true of patients who have not yet experienced defibrillator failure because of fractured leads. Those patients are told that they should not have the leads removed because the surgery is too risky, but they are concerned that at any time their defibrillator could fail, causing them extreme pain and putting their life at risk.

Many patients refer to their defibrillator as a "ticking time bomb" because they do not know if the defibrillator will one day administer an unnecessary shock or if it may not deliver a shock when needed. According to an article in the Orlando Sentinel, patients are being urged to see their cardiologists so that adjustments can be made to their defibrillators and leads. Such adjustments will cause the devices to beep if the leads break.

Some patients, such as Sarah, had their devices turned off because of the number of unnecessary shocks they received. However, Sarah says she suffered numerous shocks while the device was turned off and before it was taken out. She says she no longer trusts Medtronic's products and wants other patients to know that simply turning the device off will not guarantee that they will not be unnecessarily shocked.

Patients who have not yet had their Medtronic Sprint Fidelis leads fracture are worried about whether or not their actions will cause lead failure. Some are concerned that if they are too active, their leads are more likely to break. In some cases, they have stopped carrying out regular activities out of fear that they will experience unnecessary shocks.

According to the New York Times, one patient, a 48-year-old, decided to have the operation to remove his Sprint Fidelis Lead and defibrillator. The removal "required a painstaking 90-minute operation." The article also notes that Medtronic will only pay for a replacement lead and $800 for each surgery. But the surgeries can cost $12,500 and Medtronic will only pay for patients with fractured leads or those for whom doctors have advised removing the leads because of specific medical conditions.

The surgery itself carries risks including infection, bleeding, heart perforations and vein perforations, serious risks for any surgery, but some patients believe the risks are worth being rid of a device that is not guaranteed to work the way it was intended to, or that may not be required at all. According to the New York Times article, recent data shows that up to 80 percent of patients who receive defibrillators never require a life-saving shock from their devices.

One thing that is certain: Patients who are concerned about their Medtronic Sprint Fidelis Leads are feeling a great deal of stress over the issue. They are concerned about which activities they can and cannot do and how long it will be before their leads fracture. They wonder if the leads are still worth the risks and whether or not they should have the leads taken out. Unfortunately, there are no easy answers.