BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3232052 · Received July 17, 2013

    Report

    Report Number
    1644487-2013-02163
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    August 18, 2011
    Report Date
    June 26, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2013 DURING REVIEW OF THE PATIENT¿S PROGRAMMING HISTORY IT WAS OBSERVED THAT A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED ON (B)(6) 2011 THAT CHANGED THE PATIENT¿S SETTINGS TO OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60MIN/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. NO FINAL INTERROGATION WAS PERFORMED AND IT WASN¿T UNTIL THE PATIENT¿S NEXT VISIT ON OCTOBER 19, 2011 THAT THE SETTINGS WERE NOTICED. NO ADVERSE EVENTS WERE REPORTED TO HAVE OCCURRED DUE TO THIS SETTINGS CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331041 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR