BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAYPOINT STEREOTACTIC SYSTEM

    MDR report key: 3049548 · Received April 3, 2013

    Report

    Report Number
    3005677147-2013-00002
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MICROTARGETING PLATFORM, MICROTARGETING ELECTRODES AND INSERTION TUBES ARE SINGLE USE DEVICES USED IN MICROELECTRODE RECORDING (MER) PROCEDURE WITH A KNOWN ADVERSE EVENT OF HEMORRHAGE. IT IS A FUNCTION OF BRAIN SURGERY AND IS INHERENT TO ITS USE. THE SURGEON NOTES THAT THIS HEMORRHAGE IS NOT RELATED TO THE FUNCTIONAL ABILITY OF THE DEVICES USED IN THE INCIDENT.

    Description of Event or Problem · 1

    FHC SALES REPRESENTATIVE REPORTED TO FHC AN INCIDENT IN (B)(6) WHERE THE MICROTARGETING PLATFORM, MICROTARGETING ELECTRODES AND INSERTION TUBES WERE USED TO PERFORM DBS SURGERY. THE SURGEON DECIDED TO ABORT THE SURGERY AS HEMORRHAGING WAS OBSERVED. THE CT SCAN TAKEN AFTER THE SURGERY SHOWED A HEMORRHAGE IN THE LEFT HEMISPHERE OF THE PATIENT'S BRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137446 WAYPOINT STEREOTACTIC SYSTEM MICROTARGETING PLATFORM HAW FHC, INC. MP-KIT-02

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability