BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEUROBLATE® SYSTEM

    MDR report key: 6949324 · Received October 13, 2017

    Report

    Report Number
    3009970070-2017-00155
    Event Type
    Death
    Date Received
    October 13, 2017
    Date of Event
    March 14, 2017
    Report Date
    October 13, 2017
    Manufacturer
    MONTERIS MEDICAL CORPORATION
    Product Code
    GEX
    UDI-DI
    00816589020403
    PMA / PMN Number
    K162762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN ABLATION PROCEDURE, THE PATIENT EXPERIENCED CEREBRAL EDEMA, WAS HYPOTENSIVE, AND HAD A CHEYNE-STOKES BREATHING PATTERN. THE PATIENT WAS PRESCRIBED STEROIDS AND PLACED ON AN EXTERNAL VENTRICULOSTOMY DEVICE (RVD). ULTIMATELY, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727552 NEUROBLATE® SYSTEM NEUROBLATE® SYSTEM GEX MONTERIS MEDICAL CORPORATION 20360 00816589020403

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death