BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17551983 · Received August 15, 2023

    Report

    Report Number
    1723170-2023-01473
    Event Type
    Death
    Date Received
    August 15, 2023
    Date of Event
    July 28, 2023
    Report Date
    September 12, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2) THE PATIENT DEATH WAS REPORTED UNDER RR: 1723170-2021-02868. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    VIOZZI, I., OVERDUIN, C.G., RIJPMA, A., ROVERS, M.M., LAAN, M.T. MR-GUIDED LITT THERAPY IN PATIENTS WITH PRIMARY IRRESECTABLE GLIOBL ASTOMA: A PROSPECTIVE, CONTROLLED PILOT STUDY. JOURNAL OF NEURO-ONCOLOGY HTTPS://DOI.ORG/10.1007/SL 1060-023-04371-X PURPOSE: LASER INTERSTITIAL THERMAL THERAPY (LITI) IS INCREASINGLY BEING USED IN THE TREATMENT OF BRAIN TUMORS, WHEREAS HIGH­QUALITY EVIDENCE OF ITS EFFECTIVENESS IS LACKING. THIS PILOT EXAMINED THE FEASIBILITY OF CONDUCTING A RANDOMIZED CONTROLLED TRIAL (RCT) IN PATIENTS WITH IRRESECTABLE NEWLY DIAGNOSED GLIOBLASTOMA (NGBM), AND GENERATED DATA ON TECHNICAL FEASIBILITY AND SAFETY. METHODS: WE INCLUDED PATIENTS WITH IRRESECTABLE NGBM WITH KPS 2: 70 AND FEASIBLE TRAJECTORIES TO ABLATE 2: 70% OF THE TUMOR VOLUME. PATIENTS WERE INITIALLY RANDOMIZED TO RECEIVE EITHER BIOPSY COMBINED WITH LITI OR BIOPSY ALONE, FOLLOWED BY CHEMORADIATION (CRT). RANDOMIZATION WAS STOPPED AFTER 9 PATIENTS AS THE FEASIBILITY ENDPOINT WITH RESPECT TO WILLINGNESS TO BE RANDOMIZED WAS MET. MAIN ENDPOINTS WERE FEASIBILITY OF PERFORMING AN RCT, TECHNICAL FEASIBILITY OF LITT AND SAFETY. FOLLOW-UP WAS 3 MONTHS. RESULTS: A TOTAL OF 15 PATIENTS WERE INCLUDED, OF WHICH 10 PATIENTS RECEIVED A BIOPSY FOLLOWED BY LITI AND 5 PATIENTS A BIOPSY. MOST PATIENTS WERE ABLE TO COMPLETE THE FOLLOW-UP PROCEDURES (93% CLINICAL, 86% QUESTIONNAIRES, 78% MRI). PATIENTS WERE PLANNED WITHIN 3 WEEKS AFTER CONSULTATION (MEDIAN 12 DAYS, RANGE 8-16) AND NO DELAY WAS OBSERVED IN REFERRING PATIENTS FOR CRT (MEDIAN 37 DAYS, RANGE 28-61). TWO CD 2: 3 COMPLICATIONS OCCURRED IN THE LITI ARM AND NONE IN THE BIOPSY ARM. CONCLUSION: AN RCT TO STUDY THE EFFECTIVENESS OF LITT IN PATIENTS WITH AN IRRESECTABLE NGBM SEEMS FEASIBLE WITH ACCEPT­ABLE INITIAL SAFETY DATA. THE FINDINGS FROM THIS PILOT STUDY HELPED TO FURTHER REFINE THE DESIGN OF A LARGER FULL-SCALE MULTICENTER RCT IN THE NETHERLANDS. REPORTABLE EVENTS: ONE PATIENT IN THE LITT ARM DIED AS A RESULT OF PROGRESSIVE BLEED­ING AFTER BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792673 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Death