BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1023677 · Received April 1, 2008

    Report

    Report Number
    1644487-2008-00825
    Event Type
    Malfunction
    Date Received
    April 1, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DELL HANDHELD COMPUTER IS SUSPECTED TO HAVE A FAULTY CONNECTION THAT CONNECTS TO THE PROGRAMMING WAND. GOOD FAITH ATTEMPTS TO OBTAIN THE PRODUCT FOR PRODUCT ANALYSIS BY THE MANUFACTURER HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1