BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2171060 · Received June 30, 2011

    Report

    Report Number
    1644487-2011-01470
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 3, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD COMPUTER WOULD NOT CHARGE PAST 50% ACCORDING TO THE BATTERY INDICATOR EVEN WHILE LEFT ON THE CHARGER FOR OVER 2 DAYS. THE HANDHELD COMPUTER IS REPORTEDLY KEPT IN A LOCATION THAT DOES NOT SUBJECT IT TO HIGHER TEMPERATURES. ATTEMPTS FOR THE RETURN OF THE FAULTY HANDHELD COMPUTER ARE IN PROGRESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1