BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3181861 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10696
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER . (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A MOTOR STALL AND MOTOR STALL RECOVERY OCCURRED. BOTH EVENTS WERE RECORDED IN THE EVENT LOGS. THE PATIENT HAD AN MRI THE DAY PRIOR TO THIS REPORT. UPON THE THIRD INTERROGATION ON THE DAY OF REPORT, THE RECOVERY MESSAGE OCCURRED, THUS THE PUMP WAS IN A TELEMETRY MODE AND THE TIME OF THE ACTUAL RECOVERY WAS NOT KNOWN. IT WAS SAID THE PATIENT WAS DOING ¿FINE¿ AND THE PUMP WAS ¿PERFORMING AS EXPECTED.¿ THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282863 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR