BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 2100669 · Received May 12, 2011

    Report

    Report Number
    1644487-2011-01073
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A NURSE THAT HE WAS HAVING COMMUNICATION DIFFICULTIES USING HIS PROGRAMMING SYSTEM. FURTHER INFORMATION WAS RECEIVED FORM THE NURSE INDICATING THAT TROUBLESHOOTING CONSISTED OF CHECKING WAND'S BATTERY WHICH WAS OK. MOREOVER, THE NURSE INDICATED THAT HE HAD AN ISSUE WITH THE CONNECTION TO THE WAND AND HAD TO HOLD THE CABLE AT AN UPWARD ANGLE SOMETIMES. ADDITIONAL INFORMATION FROM A COMPANY REPRESENTATIVE REVEALED THAT A FOLLOW-UP WITH THE SITE CONFIRMED THERE WAS A PROBLEM WITH A LOOSE CONNECTOR SOCKET ON THE HANDHELD. AT THE MOMENT, A NEW PROGRAMMING WAND WAS SENT TO THE NURSE IN ORDER TO CONFIRM THE ALLEGATION OF THE HANDHELD SOCKET. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    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