BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1760898 · Received July 14, 2010

    Report

    Report Number
    1644487-2010-01623
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 14, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY THE COMPANY REPRESENTATIVE THAT SHE WAS TRYING TO INTERROGATE HER DEMO GENERATOR AND SHE EXPERIENCED A SCREEN FREEZE ISSUE AFTER INTERROGATION. SHE PERFORMED A SOFT RESET AND THE ISSUE WAS RESOLVED. MANUFACTURER HAS ALREADY IDENTIFIED THAT UNDER CERTAIN TYPE OF CONDITIONS, THIS SCREEN FREEZE EVENT CAN OCCUR WITH THE (B) (6) HANDHELD COMPUTER. NEW HANDHELD WAS SHIPPED TO THE SITE AND OLD HANDHELD WAS RETURNED FOR PRODUCT ANALYSIS. ANALYSIS IS CURRENTLY IN PROGRESS FOR THE RETURNED HANDHELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 540480

    Patients

    Seq Age Sex Outcome Treatment
    1