BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEARPOINT NEURO

    MDR report key: 13426115 · Received February 2, 2022

    Report

    Report Number
    3002838670-2021-00001
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    October 16, 2018
    Report Date
    December 6, 2021
    Manufacturer
    CLEARPOINT NEURO, INC.
    Product Code
    ORR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED UPON AN INTERNAL REVIEW, IT WAS DETERMINED THAT THIS MDR WAS NOT LISTED IN THE MAUDE DATABASE. THE REASON FOR THIS IS UNKNOWN. THIS MDR IS THUS BEING FILED RETROACTIVELY AS PER THE INSTRUCTIONS OF THE EMDR HELP DESK.

    Description of Event or Problem · 0

    DURING A CLEARPOINT PROCEDURE, THE DOCTOR INSERTED THE STYLET TO CONFIRM TARGET FOLLOWED BY INSERTION OF A VISUALASE LASER CATHETER. FOLLOWING ABLATION, THE ENTRY SITE WAS CLOSED. IT WAS LATER DETERMINED AFTER CLOSURE THAT THERE WAS A HEMORRHAGE THAT REQUIRED SURGICAL INTERVENTION. UPON FOLLOW UP, THE SURGEON COMMENTED THE PATIENT HAD FULLY RECOVERED WITH NO DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259573 CLEARPOINT NEURO SMARTFRAME XG ORR CLEARPOINT NEURO, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention