BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202629 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-01234
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    March 8, 2012
    Report Date
    May 4, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT# N305912, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT¿S PUMP WAS ORIGINAL IMPLANTED THE PHYSICIAN PUT MORPHINE IN IT. THE PATIENT WAS THEN HOSPITALIZED AGAIN FOR AN UNKNOWN REASON. IT WAS NOTED THAT THE PATIENT WAS STILL IN PAIN WITH MORPHINE IN THE PUMP. THE PHYSICIAN DRAIN THE PUMP OF MORPHINE AND WAS SLOWLY PUTTING PRIALT IN THE PUMP. THE PATIENT WAS IN THE TITRATING STAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301310 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Hospitalization