BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2061952 · Received April 5, 2011

    Report

    Report Number
    3004209178-2011-02578
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    March 23, 2011
    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

    THE PT EXPERIENCED UNDERDOSE SYMPTOMS INCLUDING NAUSEA, FLU-LIKE SYMPTOMS, AND VOMITING. THE PT FELT LIKE SHE "WANTED TO DIE". THE PT WENT TO THE ER. ON (B)(6) 2011, WHEN THEY CHECKED THE PUMP, THEY EXPECTED 15.2 ML AND THERE WAS 0 ML ASPIRATED FROM THE RESERVOIR. THIS HAD BEEN THE THIRD TIME THIS HAD HAPPENED. NO ALARMS WERE BEING HEARD. A REVISION WAS BEING CONSIDERED. IT WAS NOTED THAT PT FELT GOOD THERAPY EFFECT RIGHT AFTER A REFILL, THEN RETURN OF SYMPTOMS AS THE RESERVOIR VOLUME DECREASED. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID (10 MG/ML) AT 1 MG/DAY. 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 II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N262346018