BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1063628 · Received June 20, 2008

    Report

    Report Number
    1644487-2008-01415
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 1, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER THAT THE HAND HELD WOULD NOT POWER ON, DESPITE TROUBLESHOOTING ATTEMPTS. THE SITE HAS OPTED TO KEEP THE DEVICE AND THEREFORE THE MANUFACTURER WILL NOT PERFORM AN ANALYSIS OF THE DEVICE.

    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