BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 300-20

    MDR report key: 1941221 · Received December 16, 2010

    Report

    Report Number
    1644487-2010-02813
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: MFR REVIEWED X-RAYS OF IMPLANTED DEVICE. REVIEW OF PROGRAMMING/DEVICE DIAGNOSTIC HISTORY. RESULTS: X-RAYS REVIEWED BY THE MFR, NO GROSS LEAD DISCONTINUITIES VISUALIZED.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE PHYSICIAN THAT DIAGNOSTICS ON THE PT RESULTED IN HIGH IMPEDANCE. THERE WAS NO REPORTED TRAUMA OR MANIPULATION OF THE DEVICE. THE DEVICE WAS NOT PROGRAMMED OFF AS THE PT WAS NO EXPERIENCING ANY ADVERSE EVENTS. X-RAYS WERE TAKEN AND A COPY PROVIDED TO THE MFR. BASED ON THE X-RAY RECEIVED, THERE WERE NO GROSS FRACTURES OR LEAD DISCONTINUITY VISUALIZED THAT COULD CONTRIBUTE TO THE REPORTED HIGH IMPEDANCE. GOOD FAITH ATTEMPTS TO GAIN MORE INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 300-20 LYJ CYBERONICS, INC. 300-20 24105C

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR