BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10225501 · Received July 2, 2020

    Report

    Report Number
    1723170-2020-01767
    Event Type
    Injury
    Date Received
    July 2, 2020
    Date of Event
    December 10, 2018
    Report Date
    June 25, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. EVENT DATE IS THE ACCEPTED DATE OF THE PUBLICATION. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. PMA/510(K) IS DEPENDENT UPON THE PRODUCT NUMBER, THEREFORE THE VALUE IS UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. ADDITIONAL FDP CODES: C50672, C50579, C50487. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: ROBERT E. GROSS, MD, PHD; EDWARD K. SUNG, MD, PATRICK MULLIGAN, MD; NEALEN G. LAXPATI, MD, PHD; DARLENE A. MAYO, MD; AND JOHN D. ROLSTON, MD, PHD. ACCURACY OF FRAMELESS IMAGE-GUIDED IMPLANTATION OF DEPTH ELECTRODES FOR INTRACRANIAL EPILEPSY MONITORING.J NEUROSURG 132: 681-6901, 2020. HTTPS://THEJNS.ORG/DOI/ABS/10.3171/2018.12.JNS18749 OBJECTIVE: VARIOUS TECHNIQUES ARE AVAILABLE FOR STEREOTACTIC IMPLANTATION OF DEPTH ELECTRODES FOR INTRACRANIAL EPILEPSY MONITORING. THE GOAL OF THIS STUDY WAS TO EVALUATE THE ACCURACY AND EFFECTIVENESS OF FRAMELESS MRI-GUIDED DEPTH ELECTRODE IMPLANTATION. METHODS: USING A FRAMELESS MRI-GUIDED STEREOTACTIC APPROACH (STEALTH), DEPTH ELECTRODES WERE IMPLANTED IN PATIENTS VIA BURR HOLES OR CRANIOTOMY, MOSTLY INTO THE MEDIAL TEMPORAL LOBE.IN ALL CASES IN WHICH IT WAS POSSIBLE, POSTOPERATIVE MR IMAGES WERE COREGISTERED TO PLANNING MR IMAGES CONTAINING THE MARKED TARGETS FOR QUANTITATIVE ANALYSIS OF INTENDED VERSUS ACTUAL LOCATION OF EACH ELECTRODE TIP. IN THE SUBSET OF MR IMAGES DONE WITH SUFFICIENT RESOLUTION, QUALITATIVE ASSESSMENT OF ANATOMICAL ACCURACY WAS PERFORMED. FINALLY, THE EFFECTIVENESS OF IMPLANTED ELECTRODES FOR IDENTIFYING SEIZURE ONSET WAS RETROSPECTIVELY EXAMINED. RESULTS: SIXTY-EIGHT PATIENTS UNDERWENT FRAMELESS IMPLANTATION OF 413 DEPTH ELECTRODES (96% TO MEDIAL TEMPORAL STRUCTURES) VIA BURR HOLES BY ONE SURGEON AT 2 INSTITUTIONS. IN 26 PATIENTS (203 ELECTRODES) PLANNING AND POSTOPERATIVE MR IMAGES WERE AVAILABLE FOR QUANTITATIVE ANALYSIS; AN ADDITIONAL 8 PROCEDURES WITH 19 ELECTRODES IMPLANTED VIA CRANIOTOMY FOR GRID WERE ALSO AVAILABLE FOR QUALITATIVE ANALYSIS. THE MEDIAN DISTANCE BETWEEN INTENDED TARGET AND ACTUAL TIP LOCATION WAS 5.19MM (MEAN 6.19 + 4.13MM, RANGED <(><<)>2MM-29.4MM). INACCURACY FOR TRANSTEMPORAL DEPTHS WAS GREATER ALONG THE ELECTRODE (I.E., DEEP), AND POSTERIOR, WHEREAS ELECTRODES INSERTED VIA AN OCCIPITAL ENTRY DEVIATED RADIALLY. FAILURE TO LOCALIZE SEIZURE ONSET DID NOT RESULT FROM IMPLANTATION INACCURACY, ALTHOUGH 2 OF 62 PATIENTS (3.2%) - BOTH WITH ELECTRODES INSERTED OCCIPITALLY - REQUIRED REOPERATION. COMPLICATIONS WERE MOSTLY TRANSIENT, BUT RESULTED IN LONG-TERM DEFICIT IN 2 OF 68 PATIENTS (3%) CONCLUSIONS: DESPITE MODEST ACCURACY, FRAMELESS DEPTH ELECTRODE IMPLANTATION WAS SUFFICIENT FOR SEIZURE LOCALIZATION IN THE MEDIAL T EMPORAL LOBE WHEN USING ORTHOGONAL APPROACH, BUT MAY NOT BE ADEQUATE FOR OCCIPITAL TRAJECTORIES. REPORTED EVENTS: THREE PATIENTS EXPERIENCED INFECTIONS FOLLOWING BURR HOLE DEPTH ELECTRODE IMPLANTATION SURGERIES ONE WAS NOTED TO BE AN INTRACRANIAL ABSCESS, TWO WERE NOTED TO BE MENINGITIS, ONE PATIENT EXPERIENCED A PARENCHYMAL HEMORRHAGE OF THE LEFT TEMPORAL LOBE. THE HEMORRHAGE WAS SUSPECTED TO CONTRIBUTE TO A PERSISTENT VERBAL MEMORY DEFICIT. ONE PATIENT EXPERIENCED A SIGNIFICANT SUBDURAL HEMATOMA FROM DEPTH ELECTRODE IMPLANTATION THROUGH BURR HOLES, REQUIRING SURGICAL EVACUATION WITHOUT SEQUELAE. TWO PATIENTS EXPERIENCED TRANSIENT NEUROLOGICAL DEFICITS WITHOUT SPECIFIC ETIOLOGY. FIVE PATIENTS EXPERIENCED CEREBROSPINAL FLUID (CSF) DRAINAGE OR PSEUDOMENINGOCELE AFTER DEPTH ELECTRODE IMPLANTATION. TWO CASES OF POSTOPERATIVE WOUND INFECTION WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690056 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention