BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3063023 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06428
    Event Type
    Injury
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE THERE WAS A CEREBROSPINAL FLUID (CSF) LEAK AFTER THE DEVICE WAS FIRST IMPLANTED. THE LEAK WAS TREATED USING A BLOOD PATCH. NEAR THE TIME OF REPORT, THE PATIENT BEGAN TO HAVE HEADACHES. IT WAS NOTED THAT ONE POSSIBLE CAUSE WAS A CHRONIC CSF LEAK, THOUGH NOTHING HAD BEEN CONFIRMED. THE DEVICE SYSTEM WAS INFUSING BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166098 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention