BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1885024 · Received October 20, 2010

    Report

    Report Number
    1644487-2010-02354
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    January 1, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS FOUND ON NORMAL MODE AND SYSTEM DIAGNOSTICS. NO PAST DIAGNOSTICS ARE AVAILABLE. PT IS NONVERBAL, SO IT IS UNKNOWN IF SHE IS FEELING STIMULATION. X-RAYS WERE TAKEN AND NO OBVIOUS CAUSES FOR THE EVENT WERE VISUALIZED BY THE PHYSICIAN OR MANUFACTURER. ALTHOUGH A SHARP ANGLE WAS OBSERVED IN THE LEAD BODY, NO OBVIOUS LEAD DISCONTINUITIES WERE OBSERVED IN THE X-RAY IMAGES PROVIDED. NO PT TRAUMA OR MANIPULATION OF THE DEVICE OCCURRED. THE DEVICE HAS BEEN TURNED OFF UNTIL SURGERY CAN BE DONE. REVISION SURGERY IS PLANNED, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 011314

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR