BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENIRE

    MDR report key: 19529662 · Received June 12, 2024

    Report

    Report Number
    MW5156236
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    March 12, 2024
    Report Date
    June 10, 2024
    Manufacturer
    NEUROMOD DEVICES LIMITED
    Product Code
    QVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I USED THE LENIRE MEDICAL DEVICE TO REDUCE THE SYMPTOMS OF TINNITUS. THE DEVICE CAUSED MY RINGING TO GREATLY INTENSIFY. I WAS ENCOURAGED BY THE AUDIOLOGIST TO CONTINUE WITH THE TREATMENT. AFTER 8 WEEKS OF USE, MY TINNITUS WAS STILL EXTREMELY ELEVATED. THE AUDIOLOGIST ADJUSTED THE PROGRAMMING AND REDUCED THE DAILY TREATMENT TIME, ENCOURAGING MY CONTINUED USE OF THE PRODUCT. AFTER 12 WEEKS OF TREATMENT AND WITH NO RELIEF FROM THE REVISED PROGRAM, I DISCONTINUED USE OF LENIRE IN MARCH 2024. MY TINNITUS IS STILL ELEVATED AND I HAVE SOUGHT MENTAL COUNSELING FROM A THERAPIST TO LEARN HOW TO LIVE WITH IT. I WAS NOT ADVISED OF THIS RISK NOR DOES THE LENIRE LITERATURE DISCLOSE THIS SIDE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190118 LENIRE COMBINED ACOUSTIC AND ELECTRICAL EXTERNAL STIMULATION DEVICE FOR THE RELIEF OF T QVN NEUROMOD DEVICES LIMITED CR-201

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention ALLOPURINOL.| LEVOTHYROXINE.| TESTOSTERONE.| XYZAL.