BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTARGETING ELECTRODE

    MDR report key: 6481040 · Received April 11, 2017

    Report

    Report Number
    3002250546-2017-00003
    Event Type
    Injury
    Date Received
    April 11, 2017
    Date of Event
    March 23, 2017
    Report Date
    April 11, 2017
    Manufacturer
    FHC, INC,
    Product Code
    GZL
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2017 - THE REPORTED DEVICE WAS USED TO POSITION A LEAD OF DBS SYSTEM. DURING THE PROCEDURE, THE LEAD WAS INSERTED IN THE RIGHT BRAIN AND THEN THE PHYSICIAN CONFIRMED APPROXIMATE 5MM INACCURACY FROM THE TARGETED IMPLANT SITE. WHILE THE PHYSICIAN WAS CONSIDERING RE-INSERTION, THE CEREBRAL HEMORRHAGE OCCURRED. ON (B)(6) 2017 THE PHYSICIAN CONFIRMED THE RECOVERY OF INTRACEREBRAL HEMORRHAGE. ON (B)(6) 2017 HEMATOMA WAS SURGICALLY EVACUATED. ATTENDING PHYSICIAN'S COMMENT: IT IS SUGGESTED THAT THERE WERE WEEK AND UNRECOGNIZABLE BLOOD VESSELS AND THE CANNULA OR ELECTRODE WAS POSSIBLY PASSED THROUGH THE VESSELS. THE DEVICE IS USED TO INSERT A LEAD OF DBS SYSTEM. THE PHYSICIAN MENTIONED A POSSIBILITY THAT THE HEMORRHAGE MAY HAVE OCCURRED BECAUSE THE DEVICE TOUCHED THE FEEBLE VESSELS IN THE BRAIN. THE PHYSICIAN DOES NOT ALLEGE THE DEVICE'S MALFUNCTION. ALTHOUGH THIS EVENT MAY BE POSSIBLY CAUSED BY THE PROCEDURE OR THE VESSEL CONDITION OF THE PATIENT, THE DEVICE WAS NOT RETURNED AND THE CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262963 MICROTARGETING ELECTRODE DEPTH ELECTRODE GZL FHC, INC, FC1012 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization