BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17117025 · Received June 13, 2023

    Report

    Report Number
    1723170-2023-00986
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    April 25, 2022
    Report Date
    June 13, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 PUBLISHING 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    FERNANDEZ, C.S., ZAPATA, H.D.J, CARRETERO, M.D., GARCIA, A.F., SAENZ, C.T.A, ARRIBAS, P.J., ARIAS, C.A.R. EVALUATING THE OPTIMAL NUMBER OF BURR-HOLES FOR TREATING CHRONIC SUBDURAL HEMATOMAS: GOOD RESULTS FROM A SINGLE BURR-HOLE? POLISH JOURNAL OF NEUROLOGY AND NEUROSURGERY. 2022. 56 (4): 333-340. DOI: 10.5603/PJNNS.A2022.0030 ABSTRACT INTRODUCTION: CHRONIC SUBDURAL HEMATOMAS (CSDH) ARE ONE OF THE MOST COMMON TYPES OF TRAUMATIC INTRACRANIAL LESION. BURR­-HOLE CRANIOTOMY FOLLOWED BY CLOSED-SYSTEM DRAINAGE HAS BECOME THE TREATMENT OF CHOICE. HOWEVER, THERE IS NO DEFINITIVE INDICATION AS TO THE NUMBER OF BURR-HOLES NEEDED. OUR AIM WAS TO ASSESS CLINICAL AND RADIOLOGICAL OUTCOMES TAKING INTO ACCOUNT THE NUMBER OF BURR-HOLES MADE. MATERIAL AND METHODS: A RETROSPECTIVE SINGLE-CENTRE-STUDY WAS PERFORMED INCLUDING PATIENTS TREATED FOR CSDH BY PERFORMING BURR-HOLE CRANIOTOMY FROM 2012 TO 2018. AFTER COLLECTING DATA REGARDING DEMOGRAPHICS, COMORBIDITIES, AND CLINICAL AND RADIO­LOGICAL RECORDS, HEMATOMAS WERE GROUPED DEPENDING ON THE NUMBER OF BURR-HOLES MADE (GROUP 1: SINGLE BURR-HOLE; GROUP 2: DOUBLE BURR-HOLES). CLINICAL AND RADIOLOGICAL OUTCOMES WERE STATISTICALLY COMPARED BETWEEN GROUPS, AS WELL AS THE MAIN COM­PLICATIONS. RESULTS: AFTER COLLECTING 171 PATIENTS, 205 CSDHS WERE ANALYZED. 173 WERE TREATED WITH A SINGLE BURR-HOLE (WE CALLED THESE GROUP 1) AND 32 WITH DOUBLE BURR-HOLES (GROUP 2). NO DIFFERENCES IN PREOPERATIVE CHARACTERISTICS WERE FOUND BETWEEN THE GROUPS, EXCEPT FOR DIABETES MELLITUS AND PREVIOUS ANTIPLATELET/ANTICOAGULATION TREATMENT. NO RADIOLOGICAL DIFFERENCES WERE FOUND REGARDING HEMATOMA VOLUME (P = 0.7) OR THICKNESS (P = 0.3). SURGICAL SITE INFECTION (P = 0.13), RECURRENCE (P = 0.6), ACUTE REBLEEDING (P = 0.25) AND MORTALITY (P = 0.94) WERE ASSESSED WITHOUT EVIDENCING STATISTICALLY SIGNIFICANT DIFFERENCES. AT THE TIME OF HOSPITAL DISCHARGE, MOST PATIENTS SHOWED A REMARKABLE CLINICAL IMPROVEMENT, REGARDLESS OF THE NUMBER OF BURR-HOLES MADE (P = 0.7). CONCLUSIONS: THIS STUDY SUGGESTS THAT CSDH CAN BE EFFICIENTLY EVACUATED BY A SINGLE BURR-HOLE CRANIOTOMY, A LESS INVASIVE AND SHORTER SURGICAL PROCEDURE WITH QUITE GOOD CLINICAL OUTCOMES AND A LOW RATE OF COMPLICATIONS. REPORTED EVENTS: THE RECURRENCE FOR THE ONE-BURR HOLE WAS 12.7% AND FOR THE TWO-BURR HOLE WAS 9.4% REBLEEDING FOR THE ONE-BURR HOLE WAS 4% SURGICAL SITE INFECTION FOR THE ONE-BURR HOLE WAS 1.73% AND FOR THE TWO-BURR HOLE WAS 6.25%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251658 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention