BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC SYNCHROMED MODEL #8637-20

    MDR report key: 5690784 · Received May 26, 2016

    Report

    Report Number
    MW5062561
    Event Type
    Injury
    Date Received
    May 26, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 26, 2016
    Manufacturer
    MEDTRONIC
    Product Code
    LKK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A MEDTRONIC SYNCHROMED INTRATHECAL BACLOFEN PUMP. THE PUMP WAS IMPLANTED ON (B)(6) 2015. IT WAS TITRATED UP ADJUSTED SEVERAL TIMES AND WORKING FINE. THREE WEEKS AGO MY SPASTICITY CAME BACK, I HAD ORAL BACLOFEN ON HAND AND NOW I AM TAKING 60 MG 5 TO 6 TIMES A DAY TO GET CLOSE TO THE EFFECTS OF THE INTRATHECAL DRUG. I NOW HAVE TO HAVE A DYE TEST TO CHECK WHERE THE FRONT CATHETER IS LEAKING. MY NEUROLOGIST TOLD ME ANOTHER PT WHO HAD THE SAME PUMP IMPLANTED AROUND THE SAME TIME WITH THE SAME ISSUES. IT CANNOT BE A COINCIDENCE THAT 2 PATIENTS JUST FROM ONE OFFICE ARE HAVING THE SAME PROBLEM. EITHER THE CATHETER IS FAILING OR THE PUMP TO CATHETER CONNECTION IS FAULTY. I WORKED MANY MONTHS TO REGAIN MY MOBILITY FROM MY MS AND IT IS ALL FOR NOT. I AM BEYOND DISCOURAGED ABOUT THE MEDTRONIC SYNCHROMED PUMP AND THE AMOUNT OF LOST MONEY TO PR, ORAL BACLOFEN, AND THE NEED FOR ASSISTANCE AFTER A LONG ROAD OF IMPROVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338583 MEDTRONIC SYNCHROMED MODEL #8637-20 MEDTRONIC SYNCHROMED MODEL #8637-20 LKK MEDTRONIC 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention