BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FHC MICROELECTRODE

    MDR report key: 10425577 · Received August 19, 2020

    Report

    Report Number
    3002250546-2020-00002
    Event Type
    Injury
    Date Received
    August 19, 2020
    Date of Event
    July 23, 2020
    Report Date
    August 17, 2020
    Manufacturer
    FHC, INC.
    Product Code
    GZL
    UDI-DI
    10873263007508
    PMA / PMN Number
    K033173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANTATION OF THE DEEP BRAIN STIMULATOR (DBS) TO LEFT GPI FOR DYSTONIA. FIVE YEARS AGO THEY WERE IMPLANTED BILATERALLY STN FOR PARKINSON'S DISEASE. THE PROCEDURE WAS COMMENCED AS PER USUAL, BURR HOLE PERFORMED MER. NOTHING WAS NOTED TO BE UNUSUAL. INTRA-OPERATIVE XRAYS PERFORMED. ON REMOVAL SMALL AMOUNTS OF BLOOD IN MER CANNULA WERE OBSERVED. THE LEAD WAS IMPLANTED AND AN X-RAY WAS PERFORMED. LEADS FROM PREVIOUS IMPLANT OBSERVED THAT ONE WAS DISPLACED. CURVATURE WAS EVIDENT. A CT WAS PERFORMED AND A LARGE BASAL GANGLIA HAEMATOMA WAS EVIDENT WITH A MID LINE SHIFT. THE PATIENT RETURNED TO THE OPERATING ROOM AND A EMERGENCY VENTRICULAR CATHETER WAS INSERTED AND EXTERNAL VENTRICULAR DRAIN WAS ATTACHED. CSF WAS DRAINED. NO OBVIOUS BLOOD STAINING EVIDENT. BOTH PUPILS WERE REACTIVE AND THE PATIENT REMAINS INTUBATED. THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT. THE ISSUE IS NOT YET RESOLVED. ADDITIONAL INFORMATION WAS RECEIVED REPORTING THAT THE HEMATOMA WAS ATTRIBUTED TO THE INSERTION OF THE MER ELECTRODE WHICH IS BELIEVED TO HAVE RUPTURED A VESSEL, CAUSING THE BLEED; AND THEREFORE THE SWELLING FROM HEMATOMA IMPACT THE INSTALLED LEAD CAUSING IT TO DISPLACED. A CT WAS PERFORMED A LARGE BASAL GANGLIA HEMATOMA WAS EVIDENT WITH A MID LINE SHIFT, THE PATIENT RETURNED TO THE OPERATION ROOM AND THE EMERGENCY VENTRICULAR CATHETER WAS INSERTED AND EXTERNAL VENTRICULAR DRAIN ATTACHED. CSF WAS DRAINED AND NO OBVIOUS BLOOD STAINING WAS EVIDENT. THE PATIENT REMAINED INTUBATED AND WAS TRANSFERRED TO THE ICU. THE CONTINUE TO HAVE DAILY CT'S WHICH HAVE SHOWN THAT THE HAEMATOMA HAS NOT INCREASED IN SIZE. THEY HAVE NOT RECEIVED DETAILED INFORMATION ON THE MEDICATIONS PRESCRIBED EXCEPT THAT A STANDARD PROTOCOL FOR HAEMATOMA, HAEMORRHAGE WAS PROVIDED. THE PATIENT IS BREATHING UNASSISTED, TUBE REMAINS AND SWALLOWING NEEDS TO BE ASSESSED BEFORE REMOVAL. THEY RESPONDED TO SIMPLE COMMANDS SUCH AS HAND SQUEEZES AND EYE BLINKS. THE PATIENT HAS BEEN DISCHARGED FROM THE ICU, AND TRANSFERRED TO A WARD. THIS WAS CONFIRMED WITH THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892005 FHC MICROELECTRODE DEPTH ELECTRODE GZL FHC, INC. FC2002 244447 10873263007508

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization