BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1915546 · Received November 5, 2010

    Report

    Report Number
    3004209178-2010-08939
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    January 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    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

    A SUSPECTED INFECTION WAS REPORTED. IT WAS NOTED THAT THE PUMP WAS FOUND WITH TOO MUCH DRUG REMAINING, AND ALSO TOO LITTLE DRUG REMAINING, UPON PAST REFILL SESSIONS. IT WAS NOTED UPON THE LAST/CURRENT REFILL SESSION THAT THE DRUG WAS CLOUDY. THE PT'S OUTCOME, IN ADDITION TO THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A F/U REPORT AS IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR CATHETER: MODEL 8709SC, LOT#: N144663001| IMPLANTED:| EXPLANTED: