BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12599442 · Received October 8, 2021

    Report

    Report Number
    1723170-2021-02462
    Event Type
    Injury
    Date Received
    October 8, 2021
    Date of Event
    July 1, 2021
    Report Date
    October 8, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENTS IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND IS THEREFORE, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURE DATE IS DEPENDENT ON THE DEVICE LOT/SERIAL NUMBER, THEREFORE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    VOETS, N.L., PRETORIUS, P., BIRCH, M.D., APOSTOLOPOULOS, V., STACEY, R., PLAHA, P. DIFFUSION TRACTOGRAPHY FOR AWAKE CRANIOTOMY: ACCURACY AND FACTORS AFFECTING SPECIFICITY. JOURNAL OF NEURO-ONCOLOGY (2021) 153:547¿557. HTTPS://DOI.ORG/10.1007/S11060-021-03795 INTRODUCTION: DESPITE EVIDENCE OF CORRESPONDENCE WITH INTRAOPERATIVE STIMULATION, THERE REMAINS LIMITED DATA ON MRI DIFFUSION TRACTOGRAPHY (DT)¿S SENSITIVITY TO PREDICT MORBIDITY AFTER NEUROSURGICAL ONCOLOGY TREATMENT. OUR AIMS WERE: (1) EVALUATE DT AGAINST SUBCORTICAL STIMULATION MAPPING AND PERFORMANCE CHANGES DURING AND AFTER AWAKE NEUROSURGERY; (2) EVALUATE UTILITY OF EARLY POST-OPERATIVE DT TO PREDICT RECOVERY FROM POST-SURGICAL DEFICITS. METHODS: WE RETROSPECTIVELY REVIEWED OUR FIRST 100 AWAKE NEUROSURGERY PROCEDURES USING DT- NEURONAVIGATION. INTRA-OPERATIVE STIMULATION AND PERFORMANCE OUTCOMES WERE ASSESSED TO CLASSIFY DT PREDICTIONS FOR SENSITIVITY AND SPECIFICITY CALCULATIONS. POST-OPERATIVE DT DATA, AVAILABLE IN 51 PATIENTS, WERE INSPECTED FOR TRACT DAMAGE. RESULTS: 91 ADULT BRAIN TUMOR PATIENTS (MEAN 49.2 YEARS, 43 WOMEN) UNDERWENT 100 AWAKE SURGERIES WITH SUBCORTICAL STIMULATION BETWEEN 2014 AND 2019. SENSITIVITY AND SPECIFICITY OF PRE-OPERATIVE DT PREDICTIONS WERE 92.2% AND 69.2%, VARYING AMONG TRACTS. POST-OPERATIVE DEFICITS OCCURRED AFTER 41 PROCEDURES (39%), BUT WERE PROLONGED (>3 MONTHS) IN ONLY 4 PATIENTS (4%). POST-OPERATIVE DT IN GENERAL CONFIRMED SURGICAL PRESERVATION OF TRACTS. POST-OPERATIVE DT ANTICIPATED COMPLETE RECOVERY IN A PATIENT WITH SUPPLEMENTARY MOTOR AREA SYNDROME, AND INDICATED INFARCT-RELATED DAMAGE TO CORTICOSPINAL FIBERS ASSOCIATED WITH DELAYED, PARTIAL RECOVERY IN A SECOND PATIENT. CONCLUSIONS: PRE-OPERATIVE DT PROVIDED VERY ACCURATE PREDICTIONS OF THE SPATIAL LOCATION OF TRACTS IN RELATION TO A TUMOR. AS EXPECTED, HOWEVER, THE PRESENCE OF A TRACT DID NOT INFORM ITS FUNCTIONAL STATUS, RESULTING IN VARIABLE DT SPECIFICITY AMONG INDIVIDUAL TRACTS. WHILE PROLONGED DEFICITS WERE RARE, DT IN THE IMMEDIATE POST-OPERATIVE PERIOD OFFERED ADDITIONAL POTENTIAL TO MONITOR NEUROLOGICAL DEFICITS AND ANTICIPATE RECOVERY POTENTIAL. REPORTABLE EVENTS: IN FOUR PATIENT THERE WERE MINOR WOUNDS LEAKS/INFECTIONS FIVE PATIENT HAD PERSISTING DEFICITS WHICH WERE TRANSIENT ONE PATIENT HAD PERSISTING MOTOR SMA SYNDROME ONE PATIENT HAD RESIDUAL LOWER LIMB WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495223 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other