BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12625730 · Received October 13, 2021

    Report

    Report Number
    1723170-2021-02499
    Event Type
    Injury
    Date Received
    October 13, 2021
    Date of Event
    August 3, 2021
    Report Date
    October 13, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    RUNGE, J., ASCENCAO, L.C., BLAHAK, C., KINFE, T.M., SCHRADER, C., WOLF, M.E., SARYYEVA, A., KRAUSS, J.K. DEEP BRAIN STIMULATION IN PATIENTS ON CHRONIC ANTIPLATELET OR ANTICOAGULATION TREATMENT. ACTA NEUROCHIRURGICA 2021. HTTPS://DOI.ORG/10.1007/S00701-021-04931 BACKGROUND: IN THE AGING SOCIETY, MANY PATIENTS WITH MOVEMENT DISORDERS, PAIN SYNDROMES, OR PSYCHIATRIC DISORDERS WHO ARE CANDIDATES FOR DEEP BRAIN STIMULATION (DBS) SURGERY SUFER ALSO FROM CARDIOVASCULAR CO-MORBIDITIES THAT REQUIRE CHRONIC ANTIPLATELET OR ANTICOAGULATION TREATMENT. BECAUSE OF A PRESUMED INCREASED RISK OF INTRACRANIAL HEMORRHAGE DURING OR AFTER SURGERY AND LIMITED KNOWLEDGE ABOUT PERIOPERATIVE MANAGEMENT, CHRONIC ANTIPLATELET OR ANTICOAGULATION TREATMENT OFTEN HAS BEEN CONSIDERED A RELATIVE CONTRAINDICATION FOR DBS. HERE, WE EVALUATE WHETHER OR NOT THERE IS AN INCREASED RISK FOR INTRACRANIAL HEMORRHAGE OR THROMBOEMBOLIC COMPLICATIONS IN PATIENTS ON CHRONIC TREATMENT (PAUSED FOR SURGERY OR BRIDGED WITH SUBCUTANEOUS HEPARIN) AS COMPARED TO THOSE WITHOUT. METHODS: OUT OF A SERIES OF 465 PATIENTS UNDERGOING FUNCTIONAL STEREOTACTIC NEUROSURGERY, 34 PATIENTS WERE IDENTIFIED WHO WERE ON CHRONIC TREATMENT BEFORE AND AFTER RECEIVING DBS. IN PATIENTS WITH ANTIPLATELET TREATMENT, MEDICATION WAS STOPPED IN THE PERIOPERATIVE PERIOD. IN PATIENTS WITH VITAMIN K ANTAGONISTS OR NOVEL ORAL ANTICOAGULANTS (NOACS), HEPARIN WAS USED FOR BRIDGING. ALL PATIENTS HAD POSTOPERATIVE STEREOTACTIC CT SCANS, AND WERE FOLLOWED UP FOR 1 YEAR AFTER SURGERY. RESULTS: IN PATIENTS ON CHRONIC ANTIPLATELET OR ANTICOAGULATION TREATMENT, INTRACRANIAL HEMORRHAGE OCCURRED IN 2/34 (5.9%) DBS SURGERIES, WHEREAS THE RATE OF INTRACRANIAL HEMORRHAGE WAS 15/431 (3.5%) IN THOSE WITHOUT, WHICH WAS STATISTICALLY NOT SIGNIFICANT. IMPLANTABLE PULSE GENERATOR POCKET HEMATOMAS WERE SEEN IN 2/34 (5.9%) SURGERIES IN PATIENTS ON CHRONIC TREATMENT AND IN 4/426 (0.9%) WITHOUT. THERE WERE ONLY 2 INSTANCES OF THROMBOEMBOLIC COMPLICATIONS WHICH BOTH OCCURRED IN PATIENTS WITHOUT CHRONIC TREATMENT. THERE WERE NO HEMORRHAGIC COMPLICATIONS DURING FOLLOW-UP FOR 1 YEAR. CONCLUSIONS: DBS SURGERY IN PATIENTS ON CHRONIC ANTIPLATELET OR ANTICOAGULATION TREATMENT IS FEASIBLE. ALSO, THERE WAS NO INCREASED RISK OF HEMORRHAGE IN THE FIRST YEAR OF FOLLOW-UP AFTER DBS SURGERY. APPROPRIATE PATIENT SELECTION AND STANDARDIZED PERIOPERATIVE MANAGEMENT ARE NECESSARY TO REDUCE THE RISK OF INTRACRANIAL HEMORRHAGE AND THROMBOEMBOLIC COMPLICATIONS. REPORTABLE EVENTS: THERE WAS ONE PATIENT WHO SUFFERED FROM MILD INTRAOPERATIVE AIR EMBOLISM WITH COUGHING, BUT WITHOUT DYSPNEA OR HEMODYNAMIC INSTABILITY. A (B)(6) YEAR-OLD MAN HAD AN INTRAVENTRICULAR HEMORRHAGE ASSOCIATED WITH A TRANSVENTRICULAR ELECTRODE IN THE POSTOPERATIVE CT. AFTER FOUR ASYMPTOMATIC DAYS, HIS CONDITION WORSENED DUE TO HYDROCEPHALUS, REQUIRING AN EXTERNAL VENTRICULAR DRAINAGE FOR 5 DAYS. A (B)(6) YEAR-OLD WOMAN HAD A SMALL, ASYMPTOMATIC INTRACEREBRAL BLEEDING ALONG THE ELECTRODE TRAJECTORY IN THE POSTOPERATIVE CT SCAN. THERE WERE NO LONGTERM CONSEQUENCES. 16 PATIENTS HAD ARTERIAL HYPERTENSION. 2 PATIENTS HAD IPG POCKET HEMATOMAS SEE LITERATURE ARTICLE ATTACHED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520971 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other