BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1172593 · Received September 19, 2008

    Report

    Report Number
    1644487-2008-02252
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDHELD DEVICE WOULD FREEZE ON THE PARAMETERS SCREEN THAT APPEARS AFTER DEVICE INTERROGATION. TROUBLESHOOTING SUCH AS PERFORMING A SOFT RESET OF THE HANDHELD, USING DIFFERENT WANDS, AND ENSURING THAT THE HANDHELD WAS NOT PLUGGED IN DURING USE AND THE ISSUE DID NOT RESOLVE. THE PRODUCT WAS RETURNED TO THE MANUFACTURER HOWEVER, PRODUCT ANALYSIS HAS NOT BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521404

    Patients

    Seq Age Sex Outcome Treatment
    1