BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3251808 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12401
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    A REPRESENTATIVE REPORTED THAT, FOLLOWING A PUMP REPLACEMENT ON (B)(6) 2013, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013. THEY HAD EXHIBITED WITHDRAWAL SYMPTOMS INCLUDING ALTERED MENTAL STATUS. THEIR SYMPTOMS WERE IMPROVING AFTER TAKING ORAL BACLOFEN. COMPOUNDED BACLOFEN WAS USED AT REPLACEMENT. THE PATIENT WAS SEEN ON (B)(6) 2013 AND REFILLED WITH GABLOFEN 2000 MCG/ML AT 1130 MCG/DAY. IT WAS LATER REPORTED THAT THE PATIENT WAS DOING WELL. IT WAS SUSPECTED THAT THE PATIENT¿S SYMPTOMS WERE CAUSED BY A REACTION TO ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352614 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Hospitalization