BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2152417 · Received June 22, 2011

    Report

    Report Number
    1644487-2011-01402
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE HANDHELD DEVICE SCREEN HAD BECOME FADED AND DISCOLORED. THE PROGRAMMING SYSTEM HOWEVER, CONTINUED TO FUNCTION NORMALLY. THE HANDHELD STYLUS HAD ALSO BEEN BROKEN. THE PHYSICIAN'S OFFICE WAS UNAWARE OF ANY EVENTS THAT OCCURRED WHICH COULD HAVE CAUSED THE SCREEN ISSUES. THE DEVICE HAS SINCE BEEN RETURNED TO THE MFR FOR PRODUCT ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 857373

    Patients

    Seq Age Sex Outcome Treatment
    1