BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2352288 · Received November 30, 2011

    Report

    Report Number
    1644487-2011-02885
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Date of Event
    October 23, 2007
    Report Date
    November 10, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE VNS PATIENT'S PROGRAMMING HISTORY ON (B)(6) 2011, IT WAS DISCOVERED THAT ON DATE OF IMPLANT, (B)(6) 2007, A FAULTED SYSTEM DIAGNOSTICS TEST OCCURRED THAT CHANGED THE PATIENT'S SETTINGS FROM OUTPUT=0MA/FREQUENCY=30HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=180SEC/MAGNET OUTPUT=0MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=60SEC TO OUTPUT=1MA/FREQUENCY=20HZ/PULSE WIDTH=500USEC/ON TIME=30SEC/OFF TIME=60SEC/MAGNET OUTPUT=1MA/MAGNET PULSE WIDTH=500USEC/MAGNET ON TIME=30SEC. ALTHOUGH THE PATIENT WAS INTERROGATED AFTERWARDS, THE PATIENT'S SETTINGS WERE NOT CORRECTED UNTIL THEIR NEXT VISIT ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC MODEL 250 523494

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR