BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUEROMOD LENIRE

    MDR report key: 18494670 · Received January 10, 2024

    Report

    Report Number
    MW5150147
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    November 15, 2023
    Report Date
    January 8, 2024
    Manufacturer
    NUEROMOD / NEUROMOD DEVICES LIMITED
    Product Code
    QVN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE LENIRE DEVICE FOR TINNITUS RECEIVED DE NOVO APPROVAL LAST YEAR. THIS LED ME TO SPEND OVER (B)(6) GETTING THE DEVICE. IT SEEMED TO CAUSE RATHER SEVERE BRAIN FOG IN ME THAT LASTED A FEW WEEKS AFTER STOPPING USE OF THE DEVICE. THE DEVICE FAILED IN ANY WAY TO IMPROVE MY TINNITUS ONCE THE BRAIN FOG CLEARED UP. IT CAME ACROSS AS A BIG SCAM TO ME. HOPEFULLY, OTHERS WILL HAVE BETTER RESULTS, BUT I BELIEVE IT BEARS WATCHING. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677139 NUEROMOD LENIRE COMBINED ACOUSTIC AND ELECTRICAL EXTERNAL STIMULATION DEVICE FOR THE RELIEF OF T QVN NUEROMOD / NEUROMOD DEVICES LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male ATORVASTATIN.| CALCIUM SUPPLEMENT.| CLOPIDOGREL.| HYDROCHLOROTHIAZUDE.| LEVOTHYROXINE.| MVI .| OLMESARTAN.| RESTORIL.| TOPICAL MINOXIDIL.| VITAMIN C.