BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NERIVO

    MDR report key: 13863387 · Received March 22, 2022

    Report

    Report Number
    MW5108464
    Event Type
    Injury
    Date Received
    March 22, 2022
    Date of Event
    March 13, 2022
    Report Date
    March 21, 2022
    Manufacturer
    THERANICA BIO-ELECTRONICS LTD
    Product Code
    QGT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING THE NERIVO DEVICE TO TREAT A MIGRAINE. I'VE USED THESE DEVICES IN THE PAST WITH NO ISSUES THIS IS THE 16TH TIME THAT I USED A NERIVO DEVICE. THIS TIME, WHILE USING IT, I RECEIVED SHOCKS UP AND DOWN MY LEFT ARM. IT WAS SET TO AN INTENSITY OF 49% AT THAT TIME. I PREVIOUSLY HAD TREATMENTS USING AN INTENSITIES UP TO 60%. I EVENTUALLY REMOVED THE DEVICE AND STOPPED TREATMENT EARLY. I WAS SITTING DOWN ON A COUCH WHILE USING IT. THE TEMPERATURE IN THE HOUSE WAS APPROXIMATELY 68 DEGREES, I WAS WEARING A SHORT-SLEEVE SHIRT AND I WAS NOT SWEATING. THE DEVICE WAS ON MY LEFT UPPER ARM. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311054 NERIVO DISTAL TRANSCUTANEOUS ELECTRICAL STIMULATOR FOR TREATMENT OF ACUTE MIGRAINE QGT THERANICA BIO-ELECTRONICS LTD FGD000075

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Other ELIQUIS| ZINC| ATORVASTATIN CALCIUM| B12| CALCIUM| COSENTYX| D3| DILTIAZEM HYDROCHLORIDE ER| FISH OIL| KELP| QULIPTA| TAMSULOSIN HCL