BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED LOL

    MDR report key: 4834816 · Received June 2, 2015

    Report

    Report Number
    MW5043008
    Event Type
    Injury
    Date Received
    June 2, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 2, 2015
    Manufacturer
    SYNCHROMED LOL
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC PAIN PUMP SYNCHROMED 11 MY DR USED A VARIETY OF PAIN MEDS IN MY PUMP. SOME HAD PRESERVATIVES. THE POLYMER CATHETER AND / OR PUMP BLADDER HAD A CHEMICAL REACTION BREAKING DOWN CAUSING BRAIN DAMAGE. AFTER HAVING THE PUMP REMOVED I AM ABLE TO PROCESS THOUGHT BUT FOR TWO YEARS I WOULD HAVE BEEN CONSIDERED MENTALLY HANDICAPPED. I HAVE NOT REGAINED ALL Y MENTAL ABILITY BACK YET BUT I FEEL MENTALLY BETTER EVERY DAY. I WOULD LIKE TO KNOW THE CHEMICAL MAKEUP OF THE CATHETER AND BLADDER AND WHAT MED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357285 MEDTRONIC SYNCHROMED LOL MEDTRONIC SYNCHROMED PAIN PUMP LKK SYNCHROMED LOL 8637-20 CC116

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Disability ALEVE| PAIN MEDS