BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2230824 · Received September 1, 2011

    Report

    Report Number
    1644487-2011-02040
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    November 15, 2005
    Report Date
    August 25, 2011
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER REVIEW OF A PATIENT'S VNS PROGRAMMING HISTORY REVEALED THAT THE PATIENT WAS FOUND TO BE AT UNINTENDED VNS SETTINGS ON (B)(6) 2006. AT THE PREVIOUS VISIT ON (B)(6) 2005, A SYSTEMS DIAGNOSTICS TEST WAS PERFORMED, BUT NO FINAL INTERROGATION WAS DONE TO VERIFY SETTINGS AFTER THE TEST. IT IS LIKELY THE SYSTEMS TEST FAULTED, CAUSING THE SETTINGS TO CHANGE AND THIS WAS NOT NOTED UNTIL THE NEXT INTERROGATION ON (B)(6) 2006, WHEN THE SETTINGS WERE THEN CORRECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR