BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 2182332 · Received July 22, 2011

    Report

    Report Number
    MW5021512
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    May 1, 2010
    Report Date
    July 22, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    KWQ
    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 SURGERY FOR TWO HERNIATED DISCS IN MY NECK. THE SURGEON USED A PRODUCT MADE BY MEDTRONIC, CALLED A CERVICAL VENTURE PLATE, TO FUSE THE AFFECTED VERTEBRAE TOGETHER. ONE MONTH AFTER SURGERY, I EXPERIENCED UNUSUAL SYMPTOMS. INSOMNIA, RACING HEART, DIARRHEA, CONSTANT URINATION, HEADACHES, CONFUSION, EXTREME FATIGUE AND UNUSUAL SIDE EFFECTS TO MEDICATION THAT I DID NOT HAVE IN THE PAST. AFTER MONTHS OF TESTS, THE DOCTORS COULD NOT FIND ANYTHING WRONG. LAYING IN BED ONE DAY, I TRIED TO PUT TOGETHER THAT WAS DIFFERENT WITH MY BODY SINCE THE SURGERY AND I HAD THE REVELATION THAT I HAD A PIECE OF METAL IN MY BODY. I FINALLY FOUND A TOXICOLOGIST WHO DREW BLOOD FOR THE METALS IN MY PLATE. WHILE NONE OF THE LEVELS WERE TOXIC, THEY WERE SEVERELY ELEVATED. ONE WEEK AFTER THE SURGEON REMOVED THE PLATE, MY SYMPTOMS WERE GONE AND MY BLOOD TESTS FOR THE METAL WERE NORMAL. ALTHOUGH I CAN NOT AFFORD TO HAVE THE PLATE ANALYZED, THE DOCTOR IS QUITE CONFIDENT THAT THE PLATE CORRODED INSIDE OF MY BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC CERVICAL VENTURE PLATE KWQ MEDTRONIC ?

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Disability