BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENIRE

    MDR report key: 18204928 · Received November 22, 2023

    Report

    Report Number
    MW5148464
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 20, 2023
    Manufacturer
    NEUROMOD DEVICES LIMITED
    Product Code
    QVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I BEGAN TREATMENTS (REDUCE TINNITUS SYMPTOMS) USING THE NEUROMOD LENIRE DEVICE ON (B)(6) 2023. THE TREATMENT CONSISTS OF (2) 30-MINUTE SESSIONS PER DAY. I LOGGED EACH SESSION IN A GOOGLE DOC ALONG WITH A RATING OF THE SEVERITY OF MY TINNITUS AND ANY NOTES ABOUT HOW I WAS FEELING ABOUT MY TINNITUS EACH DAY TO SHOW PROGRESS OR IMPROVEMENTS IN MY TINNITUS CONDITION. AFTER 90 DAYS THERE IS NO IMPROVEMENT IN TINNITUS AND I FEEL MY CONDITION IS 10% TO 15% WORSE THAN WHEN I BEGAN TREATMENTS. THE DEVICE ALSO FUNCTIONED POORLY AFTER 60 DAYS AND WOULD NEED TO BE RESTARTED AS MANY AS 7-8 TIMES PER SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1830857 LENIRE COMBINED ACOUSTIC AND ELECTRICAL EXTERNAL STIMULATION DEVICE QVN NEUROMOD DEVICES LIMITED NEUROMOD LENIRE (CR-201)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male A-REDS| ALPHA-LIPOIC ACID| AMLODIPINE| ATORVASTATIN| MAGNESIUM| MENS MULTIVITAMIN| VIT D