BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1220047 · Received October 31, 2008

    Report

    Report Number
    1644487-2008-02649
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 7, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER INDICATED THE MANUFACTURER CONSULTANT THAT THEIR (B) (4) HANDHELD COMPUTER NEEDS TO BE REPLACED. REPORTED SCREEN FREEZING EVENTS THAT WOULD RESOLVE WITH A FLASHCARD REINSERTION. ADDITIONALLY IT WAS REPORTED THE VNS HANDHELD WOULD NOT TURN ON. THE (B) (4) PROGRAMMING SOFTWARE AND (B) (4) HANDHELD WERE RETURNED FOR ANALYSIS. AN ANALYSIS WAS PERFORMED ON THE HANDHELD AND (B) (4) PROGRAMMING SOFTWARE AND THE REPORTED COMPLAINT COULD NOT BE DUPLICATED WITH THE SYSTEM IN ITS "AS RECEIVED" CONDITION. THE HANDHELD PERFORMED ACCORDING TO SPECIFICATIONS. IT WAS IDENTIFIED THAT UNDER CERTAIN CONDITIONS, THE HANDHELD CAN FREEZE AFTER AN INTERROGATION IS PERFORMED. AFTER THE ANOMALY WAS INDUCED BY CREATING THE SPECIFIC CONDITIONS, THE COMPLAINT WAS VERIFIED. THE HANDHELD WAS ABLE TO BE FULLY CHARGED AND POWERED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 521396

    Patients

    Seq Age Sex Outcome Treatment
    1