BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2072397 · Received April 8, 2011

    Report

    Report Number
    1644487-2011-00711
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    November 10, 2005
    Report Date
    March 9, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PROGRAMMED SETTING CHANGE.

    Description of Event or Problem · 1

    DURING THE REVIEW OF A PATIENT'S PROGRAMMING HISTORY, IT WAS NOTED THAT ON (B)(6) 2005 THE PATIENT'S PARAMETERS WERE PROGRAMMED TO UNINTENDED SETTINGS, CAUSED BY A FAULTED SYSTEM DIAGNOSTIC TEST. THE PATIENT'S SETTINGS WERE CORRECTED, BUT NOT TO A THERAPEUTIC LEVEL AT THIS TIME. AT A LATER VISIT ON (B)(6) 2006 THE PATIENT'S GENERATOR AGAIN WAS PROGRAMMED TO UNINTENDED SETTINGS, WHICH WERE AGAIN CORRECTED TO NON-THERAPEUTIC LEVELS FOLLOWING THE FAULTED DIAGNOSTIC TEST. IT WAS NOT UNTIL (B)(6) 2006 THAT THE PATIENT WAS PROGRAMMED TO EFFICACIOUS LEVELS. VNS LABELING RECOGNIZES THE POTENTIAL FOR UNINTENDED SETTING CHANGES DUE TO COMMUNICATION ERRORS. CONSEQUENTLY, PHYSICIANS ARE ENCOURAGED TO PERFORM FINAL INTERROGATIONS TO ENSURE PROPER PATIENT 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 19 YR