BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202698 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01074
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    January 1, 2005
    Report Date
    June 12, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT OVERDOSED WITH BACLOFEN ABOUT TWO TO THREE MONTHS AFTER THEY STARTED USING IT. THE PATIENT STOPPED USING BACLOFEN AND HAD SALINE IN THE PUMP EVER SINCE. THE PATIENT WOKE UP AND COULD NOT MOVE, THE AMOUNT OF BACLOFEN INFUSED WAS ¿JUST TOO MUCH¿ FOR THE PATIENT. THE PATIENT WAS UNABLE TO USE THEIR LEGS. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED INTERMITTENT WEAKNESS IN THE LEGS. A DOSE ADJUSTMENT WAS MADE AND THE PATIENT RECOVERED WITHOUT SEQUELAE. THE DEVICE SYSTEM WAS USED TO DELIVER COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302958 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other