BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1834515 · Received September 10, 2010

    Report

    Report Number
    1644487-2010-02079
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD STARTED FREEZING ON THE INTERROGATION SCREEN. THE ISSUE RESOLVED WITH A SOFT RESET, BUT THE PHYSICIAN REQUESTED A REPLACEMENT. THE PRODUCT WAS RETURNED TO THE MANUFACTURER, BUT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521383

    Patients

    Seq Age Sex Outcome Treatment
    1