BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1885000 · Received October 20, 2010

    Report

    Report Number
    1644487-2010-02353
    Event Type
    Malfunction
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS HAVING PROBLEMS WITH HIS PROGRAMMING SYSTEM. THE PHYSICIAN WAS UNABLE TO INTERROGATE OR PERFORM DIAGNOSTICS. TROUBLESHOOTING WAS PERFORMED, BUT THE PROBLEM PERSISTED. PROGRAMMING SYSTEM WAS RETURNED TO THE MANUFACTURER, BUT ANALYSIS ON THE HANDHELD IS PENDING. ANALYSIS ON THE PROGRAMMING WAND WAS COMPLETED WHICH REVEALED NO ANOMALIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 521423

    Patients

    Seq Age Sex Outcome Treatment
    1