BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1761278 · Received July 15, 2010

    Report

    Report Number
    1644487-2010-01640
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 15, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SITE WAS HAVING ISSUES WITH THE HANDHELD AND IT WOULD KEEP FREEZING ON THE "INTERROGATION SUCCESSFUL SCREEN". MFR HAS ALREADY IDENTIFIED THAT UNDER CERTAIN TYPES OF CONDITIONS THIS SCREEN FREEZE EVENT CAN OCCUR WITH THE (B) (6) HANDHELD COMPUTER. NEW HANDHELD WAS SHIPPED TO THE SITE AND THE OLD HANDHELD WAS RETURNED BACK TO MFR FOR 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. 250 523497

    Patients

    Seq Age Sex Outcome Treatment
    1