BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING WAND

    MDR report key: 1063652 · Received June 20, 2008

    Report

    Report Number
    1644487-2008-01432
    Event Type
    Malfunction
    Date Received
    June 20, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 23, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED PHYSICIAN WAS HAVING COMMUNICATION PROBLEMS WITH THE VNS PROGRAMMING SYSTEM. HE SAID THE SURGEON WAS TRYING TO SET A PATIENT'S GENERATOR TO 0MA FOR A SURGERY THE PATIENT WAS HAVING THAT DAY, AND HE WAS NOT ABLE TO INTERROGATE. 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 WAND LYJ CYBERONICS, INC. 201

    Patients

    Seq Age Sex Outcome Treatment
    1