BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROBLATE SYSTEM

    MDR report key: 12028742 · Received June 18, 2021

    Report

    Report Number
    3009970070-2021-00016
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 28, 2021
    Report Date
    June 18, 2021
    Manufacturer
    MONTERIS MEDICAL
    Product Code
    GEX
    UDI-DI
    00816589021080
    PMA / PMN Number
    K193375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    DURING AN ABLATION PROCEDURE, IT WAS REPORTED THAT THE SURGEON NOTICED AN EPIDURAL HEMATOMA (EDH). SOME MINOR BLEEDING WAS NOTICED NEAR THE EPIDURAL HEMATOMA. THE SURGEON USED SUCTION AND FLOSEAL TO CONTROL THE BLEED AND PROCEEDED WITH THE ABLATION OPERATION. THERE WERE NO PATIENT COMPLICATIONS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921143 NEUROBLATE SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL 20980 00816589021080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention