BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 9745803 · Received February 24, 2020

    Report

    Report Number
    1723170-2020-00487
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    March 10, 2013
    Report Date
    February 12, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. 510(K) NOT PROVIDED AS SYSTEM IDENTIFIER NOT PROVIDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: SHINYA NAGAHISA, TAKEYA WATABE, HIKARU SASAKI, YUYA NISHIYAMA, TAKURO HAYASHI, MITSUHIRO HASEGAWA, YUICHI HIROSE. SURGICAL NAVIGATION-ASSISTED ENDOSCOPIC BIOPSY IS FEASIBLE FOR SAFE AND RELIABLE DIAGNOSIS OF UNRESECTABLE SOLID BRAIN TUMORS. NEUROSURG REV (2013) 36:595-601. DOI: 10.1007/S10143-013-0467-9. ABSTRACT: ABSTRACT STEREOTACTIC BIOPSY HAS BEEN VALIDATED FOR TISSUE SAMPLING OF DEEP-SEATED LESIONS THAT CANNOT BE EASILY RESECTED VIA OPEN CRANIOTOMY. HOWEVER, SOME INHERENT PROBLEMS INCLUDING THE INABILITY TO DIRECTLY OBSERVE THE LESION AND DIFFICULTY IN CONFIRMING HEMOSTASIS LIMIT ITS USEFULNESS. TO OVERCOME THESE ISSUES, WE USED THE ENDOSCOPE IN BRAIN TUMOR BIOPSY, FOR NOT ONLY INTRAVENTRICULAR TUMORS BUT ALSO INTRAPARENCHYMAL TUMORS. THE RIGID SCOPE WAS USED IN ASSOCIATION WITH A SURGICAL NAVIGATION SYSTEM FOR INTRAPARENCHYMAL LESIONS VIA A TRANSCORTICAL ROUTE. THERE WERE NO USEFUL ANATOMICAL LANDMARKS WHEN THE TRAJECTORY TO THE LESIONS WAS DECIDED; THEREFORE, SURGICAL NAVIGATION SYSTEM WAS REQUIRED FOR THE TRANSCORTICAL PROCEDURES. THE ENDOSCOPIC PROCEDURE DESCRIBED HERE WAS ATTEMPTED IN 21 CASES OF INTRAPARENCHYMAL LESIONS BETWEEN JANUARY 2007 AND FEBRUARY 2012. A DEFINITIVE DIAGNOSIS WAS OBTAINED IN ALL CASES, AND GENETIC ANALYSIS WAS PERFORMED WHEN REQUIRED. SERIOUS POSTSURGICAL HEMORRHAGE OR NEUROLOGICAL DEFICITS WERE NOT OBSERVED IN ANY CASES. ENDOSCOPIC SURGERY PROVIDES A CLEAR VIEW OF THE TARGET AND MAKES IT EASIER TO DIFFERENTIATE TUMOR TISSUE FROM NORMAL BRAIN TISSUE. MOREOVER, THE ENDOSCOPE HELPED TO CONFIRM HEMOSTASIS DURING THE PROCEDURE. THUS, ENDOSCOPIC BIOPSY HAS THE POTENTIAL TO CONTRIBUTE TOWARD SAFE AND RELIABLE DIAGNOSIS OF BRAIN TUMORS. REPORTED EVENTS: ONE (B)(6) YEAR OLD FEMALE PATIENT EXPERIENCED A SLIGHT BLEED WHICH WAS OBSERVED ON A POST-OPERATIVE COMPUTED TOMOGRAPHY (CT) SCAN. NO NEUROLOGICAL DETERIORATION WAS OBSERVED, SO THE PATIENT WAS TREATED CONSERVATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207288 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention