BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3070950 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06651
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8596SC SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER PRODUCT ID: 8709SC SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER .(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS PUT IN SO LOOSELY THAT IT SLID CLEAR ACROSS THE PATIENT'S STOMACH. WHEN THE DEVICE ALSO BEGAN FLIPPING ABOUT ONE YEAR LATER (REFER TO MANUFACTURER'S REPORT #3004209178-2013-06649), THE PUMP WAS TIGHTENED DOWN TO PREVENT FLIPPING AND MOVEMENT OVER THE PATIENT'S STOMACH. AT THE TIME OF REPORT, THE DEVICE SYSTEM WAS INFUSING MORPHINE, THOUGH IT WAS UNKNOWN IF THE DRUG HAD CHANGED SINCE THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172849 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention