BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1070433 · Received July 3, 2008

    Report

    Report Number
    1644487-2008-01535
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED A PHYSICIAN RECEIVED AN ERROR MESSAGE ON THE VNS PROGRAMMING HANDHELD. THE MESSAGE STATED "PROGRAM MEMORY LOW" "EXE ERROR". THE HANDHELD WAS RETURNED TO THE MFR AND AN ANALYSIS PERFORMED ON THE HANDHELD REVEALED NO ANOMALIES THAT SUPPORT THE REPORTED COMPLAINT. NO ANOMALIES ON THE DEVICE PERFORMANCE WERE NOTED DURING TESTING USING THE AC ADAPTER OR THE MAIN BATTERY WITH A FULL CHARGE. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 584947

    Patients

    Seq Age Sex Outcome Treatment
    1