BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2081521 · Received April 19, 2011

    Report

    Report Number
    1644487-2011-00843
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A VNS PROGRAMMING PHYSICIAN IN BANGKOK REPORTED TO OUR COUNTRY DISTRIBUTOR THAT HE HAD A POCKET HANDHELD COMPUTER HP JORNADA WHICH WAS NOT WORKING. THE PDA WAS NOT ABLE TO RECHARGE THE BATTERY; IT CAN ONLY BE OPERATED WHEN PLUGGED INTO 220V WALL OUTLET. ADDITIONALLY REPORTED THAT IT SOMETIMES WOULD NOT INTERROGATE. ELECTROMAGNETIC INTERFERENCE IS EXPECTED IF A HANDHELD IS USED PLUGGED IN. GOOD FAITH ATTEMPTS ARE UNDERWAY TO HAVE THE PRODUCT RETURNED FOR ANALYSIS. IT IS UNCLEAR AT THIS TIME IF THE OUTLET IS COMPATIBLE WITH THE HANDHELD ADAPTER OR IF IT IS A BATTERY ISSUE WITH THE HANDHELD COMPUTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 245394

    Patients

    Seq Age Sex Outcome Treatment
    1