BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17586773 · Received August 21, 2023

    Report

    Report Number
    1723170-2023-01521
    Event Type
    Death
    Date Received
    August 21, 2023
    Date of Event
    September 12, 2022
    Report Date
    November 9, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H2: THE SERIOUS INJURIES DISCUSSED IN THIS LITERATURE ARTICLE WERE REPORTED IN REGULATORY REPORT # 1723170-2023-01521 IN ERROR. THE SERIOUS INJURIES SHOULD HAVE BEEN REPORTED IN REGULATORY REPORT # 1723170-2023-01522. REGULATORY REPORT # 1723170-2023-01521 SHOULD HAVE DOCUMENTED THE DEATHS REPORTED IN THIS LITERATURE ARTICLE. PLEASE REFER TO REGULATORY REPORT # 1723170-2023-01521 FOR FURTHER REPORTS REGARDING THE REPORTED DEATHS. IT HAS BEEN DETERMINED THAT THE DEATHS REPORTED IN THE ARTICLE WERE NOT RELATED TO THE DEVICE OR THERAPY, BUT RATHER DISEASE PROGRESSION. 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

    H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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

    CITATION: WORLD NEUROSURG. (2022) 168:E119-E131. HTTPS://DOI.ORG/10.1016/J.WNEU.2022.09.053. SUMMARY: BACKGROUND: MAGNETIC RESONANCE IMAGING-GUIDED LASER INTERSTITIAL THERAPY (MRLITT) PRESENTS A NEW VALUABLE TREATMENT ALTERNATIVE WHEN THE IN-FIELD RECURRENCE (IFR) OF METASTATIC BRAIN TUMORS IS DIFFICULT TO SAFELY ACCESS WITH OPEN SURGERY OR MAXIMUM RADIATION THERAPY HAS ALREADY BEEN COMPLETED. OBJECTIVE: TO EXAMINE THE EFFECTS OF MRLITT ON LONGEVITY OUTCOMES BASED ON VOLUME OF ABLATION. METHODS: A RETROSPECTIVE STUDY WAS CARRIED OUT OF 35 PATIENTS TREATED WITH MRLITT FOR IFR AFTER RADIOSURGERY FOR METASTATIC BRAIN TUMORS AT A SINGLE INSTITUTION FROM 2010 TO 2016. OVERALL SURVIVAL (OS) AND PROGRESSION-FREE SURVIVAL (PFS) WERE ANALYZED WITH KAPLAN-MEIER AND COX REGRESSION ANALYSES ACCORDING TO ABLATION VOLUME. UNIVARIATE AND MULTIVARIATE ANALYSES FURTHER ASSESSED RISK FACTORS BASED ON ABLATION VOLUME. RESULTS: KAPLAN-MEIER ANALYSES SHOWED NO SIGNIFICANT DIFFERENCES BETWEEN TOTAL AND SUBTOTAL ABLATION GROUPS IN OS (61.1 VS. 49.7 WEEKS) AND PFS (45.1 AND 42.7 WEEKS), RESPECTIVELY (P > 0.05). IN THE SUBTOTAL ABLATION GROUP, INDEPENDENT RISK FACTORS INCLUDED PREOPERATIVE TUMOR VOLUME (HAZARD RATIO [HR], 1.24; P [ 0.05) FOR OS AND RESIDUAL TUMOR VOLUME (HR, 2.62; P [ 0.01) FOR PFS. MULTIVARIATE COX REGRESSIONS SUGGESTED NO SIGNIFICANT DIFFERENCES IN OS (HR, 1.03; P [ 0.19) AND PFS (HR, 1.02; P [ 0.24) BETWEEN TOTAL AND SUBTOTAL ABLATION GROUPS, WHEREAS PREOPERATIVE TUMOR VOLUME REMAINED A RISK FACTOR FOR DECREASED OS (HR, 1.23; P[0.004). CONCLUSIONS: MRLITT IS AN EFFECTIVE TREATMENT OPTION FOR IFR AFTER RADIOSURGERY FOR METASTATIC BRAIN TUMORS. THE BENEFITS OF MORE AGGRESSIVE GROSS TOTAL ABLATIONS OF DEEP TARGETS NEAR ELOQUENT CORTICES ARE LIMITED COMPARED WITH EFFECTIVE SUBTOTAL ABLATIONS, BUT THE AMOUNT OF RESIDUAL TUMOR VOLUME LEFT MUST BE APPROPRIATELY BALANCED. REPORTED EVENT(S): THIS WAS A RETROSPECTIVE STUDY OF 35 PATIENTS WITH 47 DIFFERENT METASTASES IN TOTAL AND AN AVERAGE AGE OF 64 YEARS. OF THESE 47, 11 PROGRESSED. 12 PATIENTS EXPERIENCED 15 COMPLICATIONS, MOST COMMONLY NEW OR INCREASED MOTOR WEAKNESS. NO OTHER COMPLICATIONS WERE SPECIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461793 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown Hospitalization| R| D