BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIMED

    MDR report key: 11998630 · Received June 15, 2021

    Report

    Report Number
    11998630
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    January 19, 2021
    Report Date
    June 11, 2021
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    GXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A CRYOABLATION, THE CURRENT KNOB WAS BEING TURNED COUNTERCLOCKWISE DOWN TO ZERO. RIGHT AT THE ZERO POINT, THE CURRENT WENT TO 100, GIVING THE PATIENT A NOTICEABLE SHOCK. THE PATIENT HAS SINCE HAD PERSISTENT PAIN AND REQUIRED ADDITIONAL OCCIPITAL NERVE BLOCKS TO DECREASE THE NERVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    895950 EPIMED DEVICE, SURGICAL, CRYOGENIC GXH EPIMED INTERNATIONAL, INC. 400-PBSYS

    Patients

    Seq Age Sex Outcome Treatment
    1 14235 DA