BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1921939 · Received December 8, 2010

    Report

    Report Number
    1644487-2010-02753
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SITE WAS HAVING ISSUES WITH TWO OF THEIR DELL X50 HANDHELD DEVICES IN THAT THEY WERE NOT HOLDING THE CORRECT DATE AND TIME AFTER MULTIPLE TRIES TO RESET AND RE-ENTER. THE FIRST HANDHELD IS REPORTED ON MDR NUMBER 1644487-2010-02692 AND THIS MDR WILL HOUSE THE SECOND HANDHELD. THE ISSUE WITH THE SECOND HANDHELD WAS NOT REPORTED TO THE MFR UNTIL (B)(6) 2010. GOOD FAITH ATTEMPTS TO OBTAIN THE HANDHELD FOR PRODUCT ANALYSIS HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 584953

    Patients

    Seq Age Sex Outcome Treatment
    1