BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12579382 · Received October 5, 2021

    Report

    Report Number
    1723170-2021-02436
    Event Type
    Death
    Date Received
    October 5, 2021
    Date of Event
    May 1, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: UNK_NAV_COMP, SERIAL/LOT #: UNK. UNK_NAV_COMP REPRESENTS THE STYLET. PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THE DATE OF DEATH WAS NOT PROVIDED IN THE ARTICLE. THE EVENT DATE WAS NOT PROVIDED. THE DATE PROVIDED WAS THE PUBLISHED ONLINE DATE. THE ARTICLE CITATION IS INCLUDED. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. THE INSTRUMENT PRODUCT NUMBER AND LOT NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS INSTRUMENT. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WORLD NEUROSURG. (2021) 149:E592-E599. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.01.128. SUMMARY BACKGROUND: INTRACEREBRAL HEMORRHAGE (ICH) IS THE MOST DEVASTATING FORM OF STROKE, WITH THALAMIC HEMORRHAGES CARRYING THE WORST OUTCOMES. MINIMALLY INVASIVE (MIS) ENDOSCOPIC ICH EVACUATION IS A PROMISING NEW THERAPY FOR THE CONDITION. HOWEVER, IT REMAINS UNCLEAR WHETHER THERAPY SUCCESS IS LOCATION DEPENDENT. HERE WE PRESENT LONG-TERM FUNCTIONAL OUTCOMES AFTER MIS EVACUATION OF SPONTANEOUS THALAMIC HEMORRHAGES. METHODS: PATIENTS PRESENTING TO A SINGLE URBAN HEALTH SYSTEM WITH SPONTANEOUS ICH WERE TRIAGED TO A CENTRAL HOSPITAL FOR MANAGEMENT OF ICH. OPERATIVE CRITERIA FOR MIS EVACUATION INCLUDED HEMORRHAGE VOLUME ¿15 ML, AGE ¿18, NATIONAL INSTITUTES OF HEALTH STROKE SCALE ¿6, AND BASELINE MODIFIED RANKIN SCORE (MRS) £3. DEMOGRAPHIC, RADIOGRAPHIC, AND CLINICAL DATA WERE COLLECTED PROSPECTIVELY, AND DESCRIPTIVE STATISTICS WERE PERFORMED RETROSPECTIVELY. FUNCTIONAL OUTCOMES WERE ASSESSED USING 6-MONTH MRS SCORES. RESULTS: ENDOSCOPIC ICH EVACUATION WAS PERFORMED ON 21 PATIENTS. ELEVEN PATIENTS HAD HEMORRHAGE CONFINED TO THE THALAMUS, WHEREAS 10 PATIENTS HAD HEMORRHAGES IN THE THALAMUS AND SURROUNDING STRUCTURES. EIGHTEEN PATIENTS (85.7%) HAD INTRAVENTRICULAR EXTENSION. THE AVERAGE PREOPERATIVE VOLUME WAS 39.8 ML (STANDARD DEVIATION [SD]: 31.5 ML) AND POSTOPERATIVE VOLUME WAS 3.8 ML (SD: 6.1 ML), RESULTING IN AN AVERAGE EVACUATION RATE OF 91.4% (SD: 11.1%). ONE MONTH AFTER HEMORRHAGE, 2 PATIENTS (9.5%) HAD EXPIRED AND ALL OTHER PATIENTS REMAINED FUNCTIONALLY DEPENDENT (90.5%). AT 6-MONTH FOLLOW-UP, 4 PATIENTS (19.0%) HAD IMPROVED TO A FAVORABLE OUTCOME (MRS £ 3). CONCLUSION: AMONG PATIENTS WITH ICH UNDERGOING MEDICAL MANAGEMENT, THOSE WITH THALAMIC HEMORRHAGES HAVE ESPECIALLY POOR OUTCOMES. THIS STUDY SUGGESTS THAT MIS EVACUATION CAN BE SAFELY PERFORMED IN A THALAMIC POPULATION. IT ALSO PRESENTS LONG-TERM FUNCTIONAL OUTCOMES THAT CAN AID IN PLANNING RANDOMIZATION SCHEMES OR SUBGROUP ANALYSES IN FUTURE MIS EVACUATION CLINICAL TRIALS. REPORTED EVENTS: FOUR PATIENTS WITH A HISTOLOGY OF ICH UNDERWENT A MIS ENDOSCOPIC ICH EVACUATION. THESE PATIENTS DIED WITH SIX MONTHS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474384 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death