BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2101703 · Received May 11, 2011

    Report

    Report Number
    1644487-2011-01048
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT SHE WAS HAVING COMMUNICATION ISSUES WITH HER PROGRAMMING SYSTEM WHICH RESOLVED BY MANIPULATING THE PLUG FROM THE SERIAL CABLE IN THE HANDHELD SOCKET. INFORMATION FROM A COMPANY REPRESENTATIVE INDICATED THAT HE CONFIRMED THE EVENT AND WAS DUE TO A PROBLEM WITH THE SOCKET IN THE HANDHELD, WHICH WITH A SMALL MOVEMENT WOULD LOOSE COMMUNICATION. GOOD FAITH ATTEMPTS TO OBTAIN THE REPORTED HANDHELD HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. MODEL 250 521371

    Patients

    Seq Age Sex Outcome Treatment
    1