BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VNS PULSE

    MDR report key: 3123518 · Received May 9, 2013

    Report

    Report Number
    3123518
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 21, 2013
    Report Date
    May 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTES FROM THE HISTORY AND PHYSICAL: "LEFT VAGAL NERVE STIMULATOR BECAME HOARSE AND OTHER EFFECTS, SO NEVER USED. WOULD LIKE REMOVED." NOTES FROM THE OPERATIVE REPORT: "AN INCISION WAS MADE IN THE UPPER CHEST IN THE SITE OF THE PREVIOUS INCISION AND BROUGHT DOWN TO EXPOSE THE PULSE GENERATOR. THIS WAS CAREFULLY DISSECTED OUT OF THE SUBCUTANEOUS POCKET. THE LEADS WERE DISSECTED OUT AS WELL...A SECOND INCISION WAS MADE IN THE LEFT SIDE OF THE NECK AT THE SITE OF THE PREVIOUS INCISION HERE AS WELL. THIS WAS BROUGHT DOWN TO EXPOSE THE LEADS AND THE 2 ANCHORS. THE ANCHORS WERE CAREFULLY REMOVED AND THE LEADS EXPOSED. THE LEADS WERE THEN GENTLY PULLED INFERIORLY UNTIL THEY CAME UNDER A SMALL AMOUNT OF TENSION. THEY WERE THEN CUT AS HIGH AS POSSIBLE AND ALLOWED TO REMAIN ATTACHED TO THE VAGUS NERVE ITSELF. THE PULSE GENERATOR AND LEADS WERE THEN REMOVED WITHOUT DIFFICULTY...THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO APPARENT COMPLICATIONS."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVAL OF VAGAL STIMULATOR.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204428 VNS PULSE STIMULATOR, AUTONOMIC NERVE LYJ CYBERONICS, INC. 102 *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR