BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IB-STIM

    MDR report key: 17246912 · Received June 30, 2023

    Report

    Report Number
    MW5119046
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 14, 2023
    Report Date
    June 28, 2023
    Manufacturer
    NEURAXIS, INC.
    Product Code
    QHH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH SYMPTOMS OF WORSENING HEADACHE, BACK PAIN, DIZZINESS WITH SECOND DEVICE (NEURAXIS IB-STIM) PLACEMENT. SYMPTOMS RESOLVED AFTER DEVICE REMOVAL. REFERENCE REPORT: MW5119047.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2040588 IB-STIM NON-IMPLANTED NERVE STIMULATOR FOR PAIN ASSOCIATED WITH IRRITABLE BOWEL SYNDROME QHH NEURAXIS, INC. 969701

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female