BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12388093 · Received August 30, 2021

    Report

    Report Number
    1723170-2021-02161
    Event Type
    Death
    Date Received
    August 30, 2021
    Date of Event
    May 1, 2021
    Report Date
    August 30, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE REFLECTS THE MEAN AGE OF PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE DATES OF DEATH WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: JEFFREY I. TRAYLOR, RAJAN PATEL, MATTHEW MUIR, DHIEGO CHAVES DE ALMEIDA BASTOS, VISWESWARAN RAVIKUMAR, CARLOS KAMIYA-MATSUOKA, GANESH RAO, JONATHAN G. THOMAS, YVONNE KEW, SUJIT S. PRABHU. LASER INTERSTITIAL THERMAL THERAPY FOR GLIOBLASTOMA: A SINGLE-CENTER EXPERIENCE. WORLD NEUROSURG. (2021) 149:E244-E252. HTTPS://DOI.ORG/10.1016/J.WNEU.2021.02.044. SUMMARY: BACKGROUND: SURGICAL RESECTION HAS BEEN SHOWN TO PROLONG SURVIVAL IN PATIENTS WITH GLIOBLASTOMA MULTIFORME (GBM), ALTHOUGH THIS BENEFIT HAS NOT BEEN DEMONSTRATED FOR REOPERATION FOLLOWING TUMOR RECURRENCE. LASER INTERSTITIAL THERMAL THERAPY (LITT) IS A MINIMALLY INVASIVE ABLATION TECHNIQUE THAT HAS BEEN SHOWN TO EFFECTIVELY REDUCE TUMOR BURDEN IN SOME PATIENTS WITH INTRACRANIAL MALIGNANCY. THE AIM OF THIS STUDY WAS TO DESCRIBE THE SAFETY AND EFFICACY OF LITT FOR RECURRENT AND NEWLY DIAGNOSED GBM AT A LARGE TERTIARY REFERRAL CENTER. METHODS: PATIENTS WITH GBM RECEIVING LITT WERE RETROSPECTIVELY ANALYZED. OVERALL SURVIVAL FROM THE TIME OF LITT WAS THE PRIMARY END POINT MEASURED. RESULTS: THERE WERE 69 PATIENTS IDENTIFIED FOR INCLUSION IN THIS STUDY. THE MEDIAN AGE OF THE COHORT WAS 56 YEARS (RANGE, 15-77 YEARS). MEDIAN TUMOR VOLUME WAS 10.4 CM3 (RANGE, 1.0-64.0 CM3). A KAPLAN-MEIER ESTIMATE OF MEDIAN OVERALL SURVIVAL FOR THE SERIES FROM THE TIME OF LITT WAS 12 MONTHS (95% CONFIDENCE INTERVAL 8-16 MONTHS). MEDIAN PROGRESSION-FREE SURVIVAL FOR THE COHORT FROM LITT WAS 4 MONTHS (95% CONFIDENCE INTERVAL 3-7 MONTHS). ADJUVANT CHEMOTHERAPY SIGNIFICANTLY PROLONGED PROGRESSION-FREE SURVIVAL AND OVERALL SURVIVAL (P < 0.01 FOR BOTH) IN THE COHORT. GROSS TOTAL ABLATION WAS NOT SIGNIFICANTLY ASSOCIATED WITH PROGRESSION-FREESURVIVAL (P = 0.09). CONCLUSIONS: LITT CAN SAFELY REDUCE INTRACRANIAL TUMOR BURDEN IN PATIENTS WITH GBM WHO HAVE EXHAUSTED OTHER ADJUVANT THERAPIES OR ARE POOR CANDIDATES FOR CONVENTIONAL RESECTION TECHNIQUES. REPORTED EVENTS: SERIOUS COMPLICATIONS LEADING TO DEATH WERE OBSERVED IN TWO PATIENTS WITH BUTTERFLY GBM TREATED WITH LITT. ONE PATIENT WITH A BUTTERFLY GBM TREATED WITH BILATERAL LITT PROBES WAS OBSERVED TO HAVE DECREASING CONSCIOUSNESS AND WORSENING OXYGEN SATURATION LEADING TO HOSPICE TRANSFER ON POST-LITT DAY 13 AND ULTIMATELY DIED SEVEN DAYS LATER. ONE PATIENT WHO RECEIVED BILATERAL LITT PROBES TO A BUTTERFLY GBM WITHIN THE SPLENIUM WAS NOTED TO HAVE HYPONATREMIA ON FOLLOW-UP. THIS WAS ULTIMATELY DIAGNOSED AS A SYNDROME OF INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION AND PROGRESSIVELY WORSENED ON REPEAT FOLLOW-UP DESPITE TREATMENT WITH CONIVAPTAN AND SALT REPLETION. THE PATIENT DIED THREE MONTHS AFTER SURGERY OWING TO PROGRESSION OF THE UNDERLYING MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285181 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death