BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRAMMING SOFTWARE

    MDR report key: 1913335 · Received November 11, 2010

    Report

    Report Number
    1644487-2010-02544
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    September 14, 2010
    Report Date
    October 26, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THE INCORRECT DATE. SUSPECT MEDICAL DEVICE LOT #, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY DID NOT REPORT THIS DATA. DEVICE MANUFACTURE DATE, CORRECTED DATA: THE INITIAL REPORT INADVERTENTLY REPORTED THIS DATA INCORRECTLY.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF PROGRAMMING HISTORY.

    Description of Event or Problem · 1

    REPORTER INDICATED A PT WAS SENSING INTERMITTENT VNS STIMULATION SHORTLY AFTER VNS GENERATOR REPLACEMENT SURGERY. THE PT WAS INFORMED THE VNS HAD BEEN DISABLED IN SURGERY. FOLLOW UP WITH THE REPORTER REVEALED THE PT'S VNS WAS INTERROGATED AND FOUND TO BE SET TO 1MA EVERY 60 MINS; THE VNS WAS THEN DISABLED. VNS PROGRAMMING HISTORY WAS OBTAINED WHICH CONFIRMED AN INTERRUPTED SYSTEMS DIAGNOSTICS TEST CAUSED THE SETTINGS TO CHANGE DURING THE IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRAMMING SOFTWARE PROGRAMMING SOFTWARE LYJ CYBERONICS, INC. 250 584948

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR