BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1220043 · Received October 31, 2008

    Report

    Report Number
    1644487-2008-02635
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR WAS HAVING PROBLEMS WITH THE HANDHELD WHILE INTERROGATING THE PATIENT. THE SCREEN KEPT DISPLAYING THE ERROR MESSAGE "DATA NOT RECEIVED". TROUBLESHOOTING DID NOT RESOLVE THE ISSUE AND CONTINUED TO SHOW THE SAME ERROR MESSAGE. THE SCREEN WOULD FREEZE AT THE INTERROGATION AND THE DOCTOR TRIED SOFT AND HARD RESET BUT NOTHING HELPED. THE DOCTOR REQUESTED FOR A NEW HANDHELD, WHICH WAS SHIPPED AND RECEIVED BY THE DOCTOR. THE NEW HANDHELD WORKED FINE. THE OLD HANDHELD WITH THE SOFTWARE HAS BEEN RETURNED TO THE MANUFACTURER AND PRODUCT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 584955

    Patients

    Seq Age Sex Outcome Treatment
    1