BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 19769574 · Received July 18, 2024

    Report

    Report Number
    1723170-2024-01721
    Event Type
    Death
    Date Received
    July 18, 2024
    Date of Event
    May 14, 2024
    Report Date
    July 18, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LJUNGQVIST, J., BARCHÉUS, H., ABBAS, F., OZANNE, A., NILSSON, D., CORELL, A. CLINICAL EXPERIENCES AND LEARNING CURVES FROM ROBOT-ASSISTED NEUROSURGICAL BIOPSIES WITH STEALTH AUTOGUIDE¿. NEURO-ONCOLOGY ADVANCES, VOLUME 6, ISSUE 1, HTTPS://DOI.ORG/10.1093/NOAJNL/VDAE079 BACKGROUND. BIOPSIES OF INTRACRANIAL LESIONS ARE A CORNERSTONE IN THE DIAGNOSIS OF UNRESECTABLE TUMORS TO GUIDE NEUROONCOLOGICAL TREATMENT; HOWEVER, THE PROCEDURE IS ALSO ASSOCIATED WITH RISKS. THE RESULTS FROM THE CRANIAL ROBOT GUIDANCE SYSTEM STEALTH AUTOGUIDE¿ WERE STUDIED AFTER INTRODUCTION AT A NEUROSURGICAL DEPARTMENT. PRIMARY AIMS INCLUDE THE PRESENTATION OF CLINICAL AND RADIOLOGICAL DATA, ACCURACY OF RADIOLOGICAL DIAGNOSIS, LEARNING CURVES OF THE NEW TECHNOLOGY, DIAGNOSTIC YIELD, AND PRECISION. THE SECONDARY AIM WAS TO STUDY COMPLICATIONS. METHODS. RETROSPECTIVE DATA INCLUSION WAS PERFORMED ON PATIENTS = 18 YEARS UNDERGOING BIOPSY WITH STEALTH AUTOGUIDE¿ DUE TO SUSPECTED BRAIN TUMORS IN THE FIRST 3 YEARS AFTER THE INTRODUCTION OF THE TECHNIQUE. DATA REGARDING CLINICAL CHARACTERISTICS, INTRAOPERATIVE VARIABLES, PATHOLOGICAL DIAGNOSIS, AND COMPLICATIONS WERE RECORDED. ANALYSES OF LEARNING CURVES WERE PERFORMED. RESULTS. A TOTAL OF 79 PROCEDURES WERE PERFORMED ON 78 PATIENTS WITH A MEAN AGE OF 62 YEARS (SD 12.7, RANGE 23¿82), 30.8% WERE FEMALE. TUMORS WERE OFTEN MULTIFOCAL (63.3%) AND SUPRATENTORIAL (89.9%). THE DIAGNOSTIC YIELD WAS 87.3%. THE FIRST-HAND RADIOLOGICAL DIAGNOSIS WAS CORRECT IN 62.0%. A SLIGHT DECREASE IN OPERATION TIME WAS OBSERVED, ALTHOUGH NOT SIGNIFICANT. THE SURGEONCONTRIBUTED TO 12% OF THE VARIABILITY. CONCLUSIONS. ROBOT-ASSISTED BIOPSIES WITH STEALTH AUTOGUIDE¿ SEEM TO BE COMPARABLE, WITH REGARDS TO COMPLICATIONS, TO FRAME-BASED AND OTHER FRAMELESS NEUROSURGICAL BIOPSIES. LEARNING CURVES DEMONSTRATED NO STATISTICAL DIFFERENCES IN TIME OF SURGERY AND ONLY 12% SURGEON-RELATED VARIATION (IE, VARIATION CAUSED BY THE CHANGE OF PERFORMING SURGEON), SUGGESTING A SUCCESSFUL IMPLEMENTATION OF THIS TECHNICAL ADJUNCT. REPORTED EVENTS: IN TOTAL 3 PATIENTS (3.8%) DIED WITHIN 30 DAYS OF SURGERY. CAUSES OF DEATH INCLUDED EPILEPSY AND LUNG EMBOLISM AT DAY 14 IN ONE PATIENT, CARDIAC ARREST, AND CIRCULATORY COLLAPSE AT DAY 28 IN ANOTHER, AND DEATH FROM TUMOR PROGRESSION IN THE LAST PATIENT. IN 2 OF THESE, THE SURGERY COULD HAVE CONTRIBUTED TO THE CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2143001 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Death