Medtronic Should Pay for Sprint Fidelis Replacement Surgery

posted on:
December 1, 2007

author:
Heidi Turner

Patients who have the now recalled Medtronic Sprint Fidelis Leads implanted face an important decision. Those who have not suffered from a malfunction must decide whether or not to have the leads capped to avoid having their defibrillator malfunction. 

Unfortunately, some people who have the leads implanted no longer have insurance coverage, so they are left wondering what they should do. Furthermore, while they still have the leads implanted they feel limited in the activities they can take part in because they do not know if their defibrillator will work the way it is meant to.

Eric Taylor (not his real name) is one such person. Last year, he suffered a massive heart attack and doctors implanted a Medtronic defibrillator and Sprint Fidelis Leads. Approximately three weeks ago, Taylor received a letter from his doctor’s office to come in and have his leads checked. At the office, Taylor’s nurse told him there was a recall on some of Medtronic’s leads and she needed to check his to see if they were recalled. Sure enough, Taylor had some of the recalled Sprint Fidelis Leads implanted.

"The nurse told me that in order to fix the problem I would need further surgery, but I have no insurance now," Taylor says. "After my serious heart attack last year, it took me more than a year to recover so I lost my job. What can I do? Who is going to pay for surgery?"

For now, the nurse has changed the settings on Taylor’s defibrillator. "Before, if my heart went above 130, the defibrillator was set to go off," Taylor says. "Now, she has changed the setting to a lower heart rate, around 100-110, so if my heart goes above that rate the defibrillator will go off. But there is no guarantee that it will work because of the defective lead. I am limited to what I can do because I do not want my heart to be at a high rate and the defibrillator to malfunction. I do not want to take a risk."

Perhaps if Taylor’s defibrillator malfunctioned, someone would take action regarding his leads. But so far, he has not experienced any problems. He has simply been told that one of his leads is "bad" and he needs to have it taken care of. "I need surgery ASAP," Taylor says. "I would have it tomorrow if I could…"

Taylor says he has tried contacting Medtronic about the issue but so far has not heard back from them. "I would like to have this problem fixed immediately, but with no insurance will they do it? Medtronic should not put defective devices into humans. Now I have to go under the knife again and there’s no guarantee I will come back alive."

 

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