BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1930339 · Received November 24, 2010

    Report

    Report Number
    1644487-2010-02682
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    August 10, 2010
    Report Date
    October 27, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN'S HANDHELD COULD NOT COMMUNICATE WITH THE GENERATOR. THEY HAD TO TRY SEVERAL TIMES BEFORE SUCCEEDING. TROUBLESHOOTING WAS PERFORMED, BUT THE PROBLEM PERSISTED. THE WAND WAS FOUND TO BE FUNCTIONING CORRECTLY, SO THE PHYSICIAN SUSPECTS A PROBLEM WITH THE HANDHELD COMPUTER. PRODUCT HAS BEEN RETURNED TO THE MFR, BUT ANALYSIS IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 537101

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR