BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NERIVIO INFINITY

    MDR report key: 24687506 · Received March 25, 2026

    Report

    Report Number
    MW5185800
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 17, 2026
    Report Date
    March 19, 2026
    Manufacturer
    THERANICA BIO-ELECTRONICS LTD.
    Product Code
    QGT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE VETERAN WAS ORDERED A NEUROLOGIC DEVICE, NERIVIO INFINITY, FOR HEADACHE RELIEF. THE DEVICE WAS CHARGING PRIOR TO USE AND EXPLODED WHILE CHARGING. THE DEVICE FELL ONTO THE VETERAN'S FLOOR AND BURNED HIS CARPET. THE VETERAN BROUGHT THE DEVICE INTO THE NEUROLOGY CLINIC AT (B)(6) MEDICAL CENTER. THE COMPANY HAS BEEN ALERTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748912 NERIVIO INFINITY DISTAL TRANSCUTANEOUS ELECTRICAL STIMULATOR FOR TREATMENT OF ACUTE MIGRAINE QGT THERANICA BIO-ELECTRONICS LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male