BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS IMPLANT

    MDR report key: 1033973 · Received April 24, 2008

    Report

    Report Number
    MW5006399
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    June 1, 2007
    Report Date
    April 24, 2007
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    SINCE I WAS IMPLANTED WITH CYBERONICS, INC VAGUS NERVE STIMULATOR IN 2007, I HAVE SUFFERED A SERIES OF ADVERSE REACTIONS. THESE INCLUDED: WEIGHT LOSS OVER A 2 MONTH PERIOD- REQUIRING 2 HOSPITALIZATIONS FOR DEHYDRATION -DUE TO ANOREXIA AND ABDOMINAL PAIN-; SEVERE LEFT EAR PAIN REQUIRING VISITS TO MY ENT AND SUBSEQUENT LOWERING OF THE STRENGTH OF STIMULATION; SEVERE SHORTNESS OF BREATH ACCOMPANIED BY AIRWAY CONSTRICTION, AND LOW BLOOD OXYGEN LEVELS REQUIRING EVALUATION BY A PULMONOLOGIST, PULMONARY FUNCTION STUDIES, AND A CAT SCAN; SLEEP HYPOPNEA DEMONSTRATED BY POLYSOMNOGRAM AND A CHOKING SENSATION. I MUST USE THE MAGNET PROVIDED BY CYBERONICS INC AT LEAST 75% OF THE TIME. THE STIMULATOR, WHICH WAS IMPLANTED FOR TRD, NEVER SEEMED TO RELIEVE MY DEPRESSION. DATES OF USE: 2007 - 2008. DIAGNOSIS OR REASON FOR USE: TRD. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VNS IMPLANT VNS IMPLANT LYJ CYBERONICS, INC. 302 39528
    2 VNS IMPLANT LEAD LYJ CYBERONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization