BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRGRAMMING SOFTWARE

    MDR report key: 1080593 · Received July 22, 2008

    Report

    Report Number
    1644487-2008-01600
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT A VNS DELL HANDHELD COMPUTER WAS FREEZING AFTER "INTERROGATION SUCCESSFUL" WAS DISPLAYED. THE EVENT WAS RESOLVED WITH A SOFT RESET. A NEW HANDHELD COMPUTER WAS SHIPPED TO THE SITE. THE PRODUCT WAS RETURNED TO THE MFR AND IS AWAITING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521404

    Patients

    Seq Age Sex Outcome Treatment
    1