BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1951971 · Received January 4, 2011

    Report

    Report Number
    3004209178-2011-00025
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 21, 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

    THE PATIENT EXPERIENCED A CHANGE IN THERAPY EFFECT. THEY HAD DIFFICULTY ASPIRATING FLUID THROUGH THE CATHETER ACCESS PORT (CAP). THE PHYSICIAN THEN INJECTED THE DYE AND IT POOLED AROUND THE PUMP AREA. NO ADD'L TROUBLESHOOTING WAS DONE AT THE TIME OF THE DYE STUDY. IT WAS UNK IF THERE WERE RESERVOIR VOLUME DISCREPANCIES. A REVISION WAS BEING DISCUSSED. THE DEVICE WAS USED TO DELIVER SUFENTANIL. 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 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N131632021