BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 4111776 · Received September 23, 2014

    Report

    Report Number
    1644487-2014-02436
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE PROBLEMS WITH THE HANDHELD DEVICE. THE PROBLEMS WERE NOT SPECIFIED AND THE HANDHELD DEVICE HAS NOT BEEN RETURNED TO DATE. NO FURTHER INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590529 PROGRAMMING SOFTWARE PROGRAMMING COMPUTER LYJ CYBERONICS MODEL 250 NI

    Patients

    Seq Age Sex Outcome Treatment
    1