BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIVION

    MDR report key: 23125070 · Received September 22, 2025

    Report

    Report Number
    MW5176411
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 18, 2025
    Report Date
    September 18, 2025
    Manufacturer
    NEUROLIEF LTD.
    Product Code
    PCC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    DEVICE SEPARATED, DEVICE FAILURE, DOES NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201595 RELIVION STIMULATOR, NERVE, ELECTRICAL, TRANSCUTANEOUS, FOR MIGRAINE PCC NEUROLIEF LTD. RELIVION MG

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Disability