Hello,
I want to share my story and see if there is anyone else out there with a similar situation. PM implanted 7/31/08 St. Jude Medical PM not sure which lead manufacturer. Leads were a blend of two things ( unclear at this point but I believe they were a mixture actually combined silicone with polyeurethane). I have been in excruiating pain since unit was installed.
At 2.5 weeks went back to EP to have things checked out. He asked why I waited so long. I should not have been in so much pain. Never having had a PM I initially dismissed the pain as healing time. PM was tender to touch, I had a burning sensation from collarbone and where my left arm joins my chest. Also, when I sat up, or typed I felt like something was constantly pecking my collarbone.
At 3 weeks, went back to hospital through ER. Had ultrasound, CT Scan, Chest X-ray, PM check all to no avail. Still no explanation for pain. Also had a patch test using the PM components done by a dermatologist. Still nothing! Went back to EP 1 week later and he scheduled me for repositioning surgery 9/16/08.
Entire unit removed and replaced with a new one The leads were corroded ( within 6wks they were from 2 different lots) EP said it looked as though they had been in me for years.
I am scared to death that new leads will also breakdown. Even though they are made differently than originals; wire, silicone cover, then polyeurethane coating.
Have any of you experienced the same symtoms? What has been your outcomes?

 

 

That my friend is abnormal and should not happen. Possibly could be due to the insulating sleeve had some damage exposing the conductor, or during the manufacturing process a problem resulted in corrosion which was not caught during the install. For example sometimes conductors are cleaned with an acid during processing and rinsed before final protective plating is applied. The acid removes oxide build-up which inihibits the adhesion of plating material. If the acid was not properly washed away, it could havbe been encapsulated inbetween the plating and base conductor. When electrical current is applied to the conductor, an electro-chemical reaction occurs causing accelerated corrosion. Just a couple possibilities.

Anyway, you can look at the implant card ST Jude sent you to find out what leads were installed, then go to their web site sjm.com and look up information on those leads. They did have a recall on some leads last year but for another reason.

Good Luck

 

Be interesting to see if any of us have those leads.