BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2842552 · Received November 21, 2012

    Report

    Report Number
    3007566237-2012-02810
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Report Date
    October 26, 2012
    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

    (B)(4).

    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 THAT THERE WAS DIFFICULTY FILLING OR ASPIRATING THE RESERVOIR. THE EVENT OCCURRED WHEN THE REPRESENTATIVE WAS IN THE OPERATING ROOM PREPARING THE PUMP FOR NEW PATIENT IMPLANT. THE REPRESENTATIVE WERE ABLE TO ASPIRATED THE WATER FROM RESERVOIR, BUT WAS UNABLE TO FILL IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THAT, FOLLOWING A WARM WATER BATH, MEDICATION WAS SUCCESSFULLY INJECTED INTO THE PUMP. IT WAS NOTED THAT THE PUMP HAD BEEN SHIPPED IN "COLDER WEATHER" THE PREVIOUS NIGHT. IT WAS REPORTED THAT, LATER, THE PUMP WAS FILLED WITH WARM SALINE. IT WAS NOTED THAT THE PATIENT WAS DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1