BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOT LABS XIENCE STENT

    MDR report key: 2479680 · Received February 29, 2012

    Report

    Report Number
    MW5024506
    Event Type
    Injury
    Date Received
    February 29, 2012
    Date of Event
    September 23, 2011
    Report Date
    February 29, 2012
    Manufacturer
    ABBOTT LABS
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD AN ABBOTT LABS XSCIENCE DES STENT PLACED ON (B)(6) 2011. THIS STOPPED ELECTRIC JOLTS TO MY HEART THAT WERE AWAKENING ME EVERY 2 HRS, BUT, I CONTINUE TO HAVE RACING, PALPITATING HEART. I ALSO CONTINUE TO HAVE ELECTRIC CURRENT SENSATIONS THROUGHOUT MY HEART, ARTERIES, NERVES IN BREAST, BRAIN, STOMACH, AND SKELETAL FRAME. I HAVE READ THAT EVEROLIMUS, THE DRUG THAT THE STENT ELUTES, IS ACTUALLY CHEMOTHERAPY/IMMUNOTHERAPY. I WAS NOT TOLD THIS BEFORE PLACEMENT OF THE STENT. I WAS ALSO NOT TOLD THAT THE METAL STENT CONSISTED OF NICKEL -- TO WHICH I AM ALLERGIC. THIS HAS RUINED MY LIFE, AS I AM NO LONGER ABLE TO HIKE, BIKE, OR SWIM FOR OVER 15 MINS AT A TIME. AND, EVEN AT THAT, THE ELECTRIC CURRENT SENSATIONS THAT I FEEL RUNNING THROUGH MY BODY INTENSIFY TO THE POINT THAT IT FEELS LIKE I AM HAVING INTERNAL VIBRATIONS. I HAVE DISCUSSED THIS WITH THE CARDIOLOGIST, WHO TOLD ME "YOU ARE IMAGINING THIS," EVEN THOUGH MY HUSBAND AND A FRIEND HAVE SEEN MY LEFT BREAST AND MY RIGHT FOOT "VIBRATING" AFTER EXERCISING, OR BECOMING STRESSED. I HAVE RESEARCHED THIS AND FOUND MANY, MANY PEOPLE POSTING ON HEALTH FORUMS WITH THESE SAME SYMPTOMS AND NONE HAVE REC'D A DIAGNOSIS. HERE ARE JUST A FEW -- I HAVE FOUND HUNDREDS BESIDES THESE: (B)(6). THIS IS HAPPENING TO ME NOW. I NOTICED IT FIRST SEVERAL DAYS AGO AND AT FIRST DIDN'T QUITE REALIZE WHAT WAS GOING ON. IT IS VERY SUBTLE. BUT IT HAS BEEN INCREASING AND RIGHT NOW IT IS HAPPENING OVER AND OVER. IT IS UNDER MY RIGHT BREAST AND YEAH, IT JUST FEELS LIKE A VERY LIGHT VIBRATION. IT IS SHORT, NO PAIN, NO FAINTNESS. JUST THIS BUZZ. I AM THINKING IT MUST HAVE TO DO WITH THE HEART'S ELECTRICAL SYSTEM, WHICH IS VERY WORRISOME, OBVIOUSLY. MY FATHER HAD TO HAVE A PACEMAKER FROM SOME TIME IN HIS (B)(6) ON, AND I AM TURNING (B)(6). I HAVE HAD A STENT IN MY LAD 10 YRS AGO AND NO RECURRENCES OF ANYTHING, BUT THIS IS OBVIOUSLY BOTHERSOME. WHAT ALL HAVE YOU ALL FOUND OUT??????? (B)(6). IN (B)(6) 2004, I WOKE TO FEEL A STRANGE FEELING LIKE A SMALL ELECTRICAL CURRENT GOING THROUGH MY UPPER BODY. IT IS NOW CONTINUOUS AND HAS BEEN FOR SOME MONTHS...HARD TO EXPLAIN BECAUSE IT IS JUST LIKE THE SLIGHTEST AMOUNT OF ELECTRICAL STIMULATION HAS BEEN HOOKED UP TO ME. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOT LABS XIENCE STENT DES XIENCE V STENT MAF ABBOTT LABS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other ABBOTT LABS XIENCE V DES STENT| EVEROLIMUS IMMUNOTHERAPY