BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 3170157 · Received June 14, 2013

    Report

    Report Number
    1644487-2013-01784
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    CYBERONICS
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013 IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO PROGRAM THE VNS PATIENT BECAUSE THE BUTTON TO PROGRAM ON THE HANDHELD SCREEN WAS NOT AVAILABLE TO PUSH. THE WAND BATTERY WAS CHECKED AND SEEMED TO BE FINE. THE PATIENT WAS SEEN AGAIN THE NEXT DAY AND THE SAME ISSUE WAS OBSERVED. THE PHYSICIAN SELECTED A PARAMETER AND THEN THE PROGRAM BUTTON STILL WASN¿T ¿HIGHLIGHTED¿ THEREFORE NOT GIVING THE USER THE CHANCE TO PROGRAM THE PARAMETER. THE PHYSICIAN UNSELECTED AND RESELECTED THE PARAMETER AND THEN THE PROGRAM BUTTON ALLOWED HER TO PROGRAM THE DEVICE. THE PHYSICIAN LATER REPORTED THAT THIS EVENT ONLY OCCURRED THESE TWO TIMES WITH THIS VERSION OF SOFTWARE AND THIS PATIENT. SHE STATED THAT SHE THINKS IT MAY HAVE BEEN DUE TO ¿USER ERROR¿ AND THAT MAYBE IT WAS BECAUSE SHE HAD IT PLUGGED IN AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271141 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS MODEL 250 1063824

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR