BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3556806 · Received January 7, 2014

    Report

    Report Number
    1644487-2014-00093
    Event Type
    Malfunction
    Date Received
    January 7, 2014
    Date of Event
    June 13, 2006
    Report Date
    December 12, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED THAT CHANGED THE PATIENT¿S SETTINGS TO OUTPUT=1MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/ MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC AT THE TIME OF IMPLANT ON (B)(6) 2006. THESE SETTINGS WERE NOT CORRECTED AND THEN A FINAL SYSTEM DIAGNOSTICS TEST APPEARED TO HAVE CHANGED THE SETTINGS AGAIN THAT DAY TO OUTPUT=0MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC AS THE PATIENT WAS INTERROGATED AND FOUND AT THESE INCORRECT SETTINGS AT THE NEXT VISIT ON (B)(6) 2006. THE SETTINGS WERE CORRECTED ON (B)(6) 2006 TO OUTPUT=0.25MA/FREQUENCY=20HZ/PULSE WIDTH=250USEC/ON TIME=30SEC/OFF TIME=10MIN/MAGNET OUTPUT=0.25MA/MAGNET PULSE WIDTH=250USEC/MAGNET ON TIME=60SEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8977 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR