BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2211895 · Received August 10, 2011

    Report

    Report Number
    1644487-2011-01827
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    September 9, 2003
    Report Date
    July 11, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    DURING REVIEW OF THE VNS PROGRAMMING HISTORY AVAILABLE TO THE MFR, IT WAS FOUND THAT A FAULTED DIAGNOSTICS TEST HAD OCCURRED THAT CAUSED THE PT'S PROGRAMMED SETTINGS TO CHANGE. THIS WAS NOT DISCOVERED UNTIL THE PT'S NEXT VISIT. THE PT'S SETTINGS WERE CORRECTED AT THAT TIME. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE CHANGE IN SETTINGS.

    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 14 YR