BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17351499 · Received July 19, 2023

    Report

    Report Number
    1723170-2023-01282
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    November 12, 2022
    Report Date
    July 19, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2) PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. A3) PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. A4) PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. B3) EVENT DATE IS THE ONLINE ACCEPTED DATE OF THE LITERATURE ARTICLE. D4) DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. G4) 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. H4) DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER / SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    DOGAN, A., DURMAZ, M.O., KUTLAY, A.M., KAYHAN, S., KRIMIZIGOZ, S., OZER, M.I. ENDOSCOPIC RESECTION OF INTRACRANIAL DERMOID AND EPIDERMOID TUMORS FROM A MINIMALLY INVASIVE PERSPECTIVE. GULHANE MED J. 2023. 65 (31-8) DOI: 10.427 4/GULHANE.GALENOS.2022.55707. ABSTRACT AIMS: INTRACRANIAL DERMOID AND EPIDERMOID TUMORS (IDETS), BENIGN, CONGENITAL LESIONS, ARE TRADITIONALLY TREATED USING OPEN SURGERY. HOWEVER, TOTAL RESECTION (TR) CAN BE DIFFICULT DUE TO ADHESIONS TO SURROUNDING STRUCTURES. WHILE ENDOSCOPIC SURGERY HAS EMERGED AS A LESS INVASIVE APPROACH, ITS SUCCESS MAY DIFFER ACROSS CENTERS. THIS STUDY EVALUATED THE OUTCOMES OF IDET ENDOSCOPIC SURGERY CASES AND COMPARED THEM WITH THE LITERATURE. METHODS: WE RETROSPECTIVELY REVIEWED PATIENTS WHO UNDERWENT AN OPERATION FOR EPIDERMOID AND DERMOID TUMORS USING AN ENDOSCOPIC APPROACH FROM 201 OTO 2020. AGE, SEX, TUMOR LOCATION, TUMOR SIZE, SURGICAL APPROACH, RESECTION RATES, INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS, LENGTH OF HOSPITAL STAY AND RECURRENCE RATES OF THE CASES WERE EVALUATED. RESULTS: THE STUDY INCLUDED 18 PATIENTS (MEAN±STANDARD DEVIATION AGE: 39.6±15.5 YEARS, AGE RANGE 15-68 YEARS, MALE SEX: N=12, 66.6%). THE TUMOR LOCATIONS WERE 2 TEMPORAL (11.1 %), 2 FRONTAL (11.1 %), AND 1 OCCIPITAL (5.5%) (ALL INTRAPARENCHYMAL); 2 FRONTOBASAL (11.1 %), 3 SUPRASELLAR (16.6%), 2 LATERAL ORBITAL (11.1 %), 1 INTRAORBITAL (5.5%), 3 CEREBELLOPONTINE ANGLE (16.6%), AND 1 LOCATED IN THE LATERAL VENTRICLE (5.5%); AND 1 LOCATED IN THE THIRD VENTRICLE (5.5%). TR, NEAR-TR AND SUBTOTAL RESECTION WERE PERFORMED IN 7 (38.8%), 5 (27.7%), AND 6 (33.3%) CASES, RESPECTIVELY. NO POSTOPERATIVE COMPLICATION WAS RECORDED EXCEPT FOR ONE PATIENT WHO DEVELPPED RHINORRHEA AND PNEUMOCEPHALY. NO INTRAOPERATIVE COMPLICATION WAS RECORDED. THE MEAN LENGTH OF HOSPITAL STAY WAS 7.9 DAYS (RANGE, 5-28 DAYS). CONCLUSIONS: IDETS CAN BE TREATED BY ENDOSCOPIC APPROACHES, WITHOUT THE NEED FOR LARGE INCISIONS AND CRANIOTOMY IN OPEN APPROACHES. DECREASED HOSPITAL STAY SEEMS TO BE THE PRIMARY ADVANTAGE OF ENDOSCOPIC SURGERY. REPORTED EVENTS: ONE PATIENT WHO DEVELOPED RHINORRHEA AND PNEUMOCEPHALY. REOPERATION OF A PATIENT WITH A FRONTOBASAL TUMOR DUE TO RHINORRHEA AND PNEUMOCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36588 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Required Intervention