BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2040755 · Received March 22, 2011

    Report

    Report Number
    6000030-2011-02169
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE UNABLE TO ACCESS THE CAP (CATHETER ACCESS PORT) ON THE PT'S PUMP. A FLIPPED PUMP WAS SUSPECTED, BUT NOT CONFIRMED. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS REPORTED AS "OTHER". ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR CATHETER: MODEL 8709, LOT# J10908R25| EXPLANTED:| IMPLANTED: