Lead recalls - Heart Disorders Message Board

leah131 · 10-16-2007, 06:21 PM

Hello all:
I have a saint jude defibrillator but medtroic leads. Does anyone know if there will be more recalls or this is it? Please let me know. Thanks
Leah

huckfinn · 10-22-2007, 06:57 AM

Medtronic Defibrillator Defective Sprint Fidelis Lead

On October 15, 2007, Medtronic announced that it was suspending sales of the Sprint Fidelis lead, a vital component in its implantable defibrillators. According to Medtronic, the Sprint Fidelis lead, a wire that connects the Medtronic defibrillator to the heart, could fracture inside a patient’s blood vessel, delivering a massive electrical jolt. This malfunction can cause extreme pain, or in the worse case scenario, it can be fatal. At least 5 deaths have already been linked to a malfunctioning Sprint Fidelis lead used with an implantable Medtronic defibrillator.

The Sprint Fidelis lead have been used in implantable Medtronic defibrillators since 2004, and most patients who received the devices since then have the faulty leads. Sprint Fidelis leads were used only in cardiac defibrillators -- or complex devices with defibrillation capacity -- and not in conventional pacemakers. Some patients with congestive heart failure use devices that included this defibrillation ability, and those were among the machines that use the Sprint Fidelis lead.

I spoke with a Lady who was in the hospital Saturday. She had heart block (very slow heart beat due to the delayed electrical signal passing through the AV node) and had to have a pacemaker implanted. She was under the impression that her St. Jude pacemaker was being recalled. I can't find any information to support her claim. I only found the information on the Defective Sprint Fidelis Lead.

I believe that she must have had the Sprint Fidelis lead from her device. She appeared to be very sick.

pandyk412 · 11-03-2007, 04:05 PM

I received my letter from Medtronic yesterday. I wasn't on the computer for days so missed it on the news. I also had a call from my heart doctor's office saying I would meet the rep. That was last Tuesday. They are going to provide a device for my telephone that monitors my defib. If I understand it correctly,an alarm goes off from the defib in my chest and I will hear it. Of course, at that point, I will be aware of some problem and call ER. Yes, I am certain that I have one of defibs that has the right/wrong numbers on them. I am certainly not being flip about this, but then, I am not completely in a panic. I am looking at the same letter you can see on the site. I have been lurking about this section for awhile reading posts and learning more about my own heart attack/stroke which was 2 1/2 years ago. My defib has been working well for me and they are not suggesting replacing these. Certainly check with your heart doctor or the rep. I will tell you when I receive this new thing when they give me a call. Hope this helps.

jessica226 · 01-22-2008, 03:17 PM

Hello...I am Jessica. I am 46 years old. You are correct about the noise from your device. My doctor called it "toning", and it isn't very loud. Sounds kind of like a door bell. I had my leads removed and replaced in Topeka Dec. 27th. They were sprint fidelis on my Medtronic pacer-defibrillator. It was discovered that my leads would not fracture. They were fine, however, I had to have my device removed and placed on the right side of my chest because I had been in pain since the device was implanted on top of a nerve two years earlier. I do not know anyone who has a device. I feel so alone with all this. Maybe we can chat?