BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2991507 · Received March 6, 2013

    Report

    Report Number
    1644487-2013-00606
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 18, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A SITE REPORTED THAT THEIR DELL X50 HANDHELD COMPUTER WAS FROZEN ON THE INTERROGATION SCREEN AND THEY COULD NOT INTERROGATE AND RUN DIAGNOSTICS. A HARD RESET WAS PERFORMED AND THE HANDHELD IS WORKING NOW. THE PATIENT WILL BE SCHEDULED TO COME BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96023 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS INC 250 840144

    Patients

    Seq Age Sex Outcome Treatment
    1