BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1973523 · Received January 19, 2011

    Report

    Report Number
    1644487-2011-00083
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A VNS TREATING PHYSICIAN REPORTED TO THEIR FIELD REP IN (B)(4) THAT THEY HAD DIFFICULTY INTERROGATING WITH THEIR PROGRAMMING SYSTEM. A NEW SERIAL CABLE WAS SENT TO THE SITE AND RULED OUT AS THE CAUSE OF THE EVENT. THE GREEN LIGHT ON THE PROGRAMMING WAND IS ILLUMINATED FOR OVER 25SECS INDICATING THAT IT HAS POWER. AT THIS TIME, GOOD FAITH ATTEMPTS ARE UNDERWAY TO DETERMINE THE CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 715907

    Patients

    Seq Age Sex Outcome Treatment
    1