BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3933055 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12999
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A STALL WAS RECORDED IN THE EVENT LOGS WITH NO MOTOR RECOVERY RECORDED. THE MOTOR STALL WAS RECORDED THE SAME DAY THE PATIENT HAD AN MRI AND A STOP PUMP PERIOD MAY EXCEED TUBE SET MESSAGED SHOWED 48 HOURS AFTER THE STALL. THE STALL WAS CAUSED BY THE PATIENT HAVING AN MRI. THE PUMP BEGAN ALARMING WHILE THE REPORT WAS OCCURRING AND HAD NOT PREVIOUSLY ALARMED. THE PATIENT WAS FIRST DESCRIBED AS ASYMPTOMATIC, BUT WAS LATER DESCRIBED AS HAVING PAIN, A LITTLE MORE THE PAST COULD OF DAYS. THE PUMP WAS USED TO DELIVER GABLOFEN (BACLOFEN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411087 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR