BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 2831558 · Received November 5, 2012

    Report

    Report Number
    3005677147-2012-00006
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 19, 2012
    Manufacturer
    FHC INC.
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MICROTARGETING ELECTRODES ARE SINGLE USE STERILE 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. THIS HEMORRHAGE IS NOT RELATED TO THE FUNCTIONAL ABILITY OF THE MT ELECTRODE USED IN THE INCIDENT.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED TO FHC QUALITY DEPARTMENT AN INCIDENT WITH THE 22670 MICROELECTRODE. BLEEDING WAS NOTICED BY THE SURGEON AFTER REMOVING THE MICROELECTRODE AND WHILE PLACING THE LEAD INTO PLACE. THE BLEEDING TOOK PLACE IN THE LEFT HEMISPHERE WHICH LEAD TO THE PATIENT BEING UNRESPONSIVE AND HEMIPLEGIC ON THE RIGHT SIDE OF THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROTARGETING ELECTRODE MT ELECTRODE GZL FHC INC. 22670 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization