BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1022715 · Received March 26, 2008

    Report

    Report Number
    1644487-2008-00794
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 28, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    REPORTER INDICATED THAT SYSTEM DIAGNOSTICS WERE NOT ABLE TO BE COMPLETED ON A PT'S PULSE GENERATOR WITHOUT RECEIVING ERROR MESSAGES, AND AT TIMES THE PT'S DEVICE SETTINGS WERE CHANGED AFTER THE ATTEMPT TO RUN DIAGNOSTICS TESTING. PROGRAMMING HANDHELD AND ACCOMPANYING SOFTWARE WERE SUBSEQUENTLY RETURNED TO MANUFACTURER FOR ANALYSIS, HOWEVER, THAT ANALYSIS IS NOT YET COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521419

    Patients

    Seq Age Sex Outcome Treatment
    1