BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1910077 · Received November 10, 2010

    Report

    Report Number
    1644487-2010-02530
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 13, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT A VNS PT WAS FOUND TO BE AT UNINTENDED SETTINGS AFTER BEING PROGRAMMED TO 1.5/20/250/30/3. THE PT WAS SEEN FOR A F/U AND WAS FOUND TO BE AT STANDARD SYSTEM DIAGNOSTIC SETTINGS 1/20/500/30/60 ON INTERROGATION. NURSE IN OFFICE STATES THAT SHE KNOWS SHE PERFORMED A FINAL INTERROGATION BEFORE PT LEFT THE OFFICE ON THAT VISIT. PT REPORTED A SLIGHT INCREASE IN SEIZURES BUT NOT ABOVE BASELINE DURING THIS TIME PERIOD. THE PT WAS RESET TO HER INTENDED PARAMETERS AFTER THE UNINTENDED SETTINGS WERE FOUND. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR