BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VNS

    MDR report key: 11561940 · Received March 23, 2021

    Report

    Report Number
    MW5100214
    Event Type
    Injury
    Date Received
    March 23, 2021
    Date of Event
    January 2, 2021
    Report Date
    March 21, 2021
    Manufacturer
    CYBERONICS / LIVANOVA USA, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD SEIZURE AND HOSPITALIZED FOR 3 WEEKS STILL NOT BEING HELPED OR TREATED FOR VNS PROBLEMS I AM A VETERAN AND THIS IS WHO HAD VNS IMPLANTED 1ST TIME BY U.S. DEPARTMENT OF VETERANS AFFAIRS. NEED HELP SEIZURES HAVE INCREASED PAIN IN NECK CHEST NOT BEING TREATED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445522 VNS STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY LYJ CYBERONICS / LIVANOVA USA, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| O| S