BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IB-STIM

    MDR report key: 22329095 · Received June 24, 2025

    Report

    Report Number
    MW5171884
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    June 10, 2025
    Report Date
    June 13, 2025
    Manufacturer
    NEURAXIS INC
    Product Code
    QHH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY SON HAD AN IRRITABLE BOWEL SYNDROME- STIMULATOR DEVICE PLACED ON (B)(6) 2025. SINCE THAT TIME, HE HAS HAD SERIOUS SLEEP DISTURBANCES. THE IB-STIM IS APPARENTLY DISRUPTING HIS CIRCADIAN RHYTHMS AND HE HAS HAD VERY LITTLE SLEEP IN THREE DAYS. THIS SIDE EFFECT WAS NOT DISCLOSED IN THE INFORMED CONSENT THAT WE SIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873391 IB-STIM NON-IMPLANTED NERVE STIMULATOR FOR PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME QHH NEURAXIS INC

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Other HOLOZYME.