BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 10101158 · Received May 29, 2020

    Report

    Report Number
    1723170-2020-01545
    Event Type
    Death
    Date Received
    May 29, 2020
    Date of Event
    September 29, 2019
    Report Date
    May 29, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE IS THE AVERAGE AGE OF THE 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. DATE OF DEATH NOT PROVIDED IN ARTICLE. THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED AS THE EVENT DATES 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 510K PROVIDED AS SYSTEM IS UNKNOWN. 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: DANIEL G EICHBERG, MD, SIMON A MENAKER, BS, WALTER J JERMAKOWICZ, MD, ASHISH H SHAH, MD, EVAN M LUTHER, MD, ARIA M JAMSHIDI, MD, ALEXA M SEMONCHE, BA, LONG DI, BS, RICARDO J KOMOTAR, MD, MICHAEL E IVAN, MD, MBS, MULTIPLE ITERATIONS OF MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL ABLATION OF BRAIN METASTASES: SINGLE SURGEON'S EXPERIENCE AND REVIEW OF THE LITERATURE, OPERATIVE NEUROSURGERY, HTTPS://DOI.ORG/10.1093/ONS/OPZ375. SUMMARY: BACKGROUND: PRIOR TREATMENT WITH MAGNETIC RESONANCE-GUIDED, LASER-INDUCED THERMAL THERAPY (LITT) IS WIDELY ASSUMED NOT TO BE A CONTRAINDICATION FOR FURTHER TREATMENT OF BRAIN LESIONS, INCLUDING FURTHER ITERATIONS OF LITT. HOWEVER, THE SAFETY AND EFFICACY OF REPEAT LITT TREATMENTS HAVE NEVER BEEN FORMALLY INVESTIGATED. OBJECTIVE: TO EVALUATE TREATMENT WITH MULTIPLE ITERATIONS OF LITT. METHODS: ALL PATIENTS TREATED WITH LITT AT LEAST TWICE AT OUR INSTITUTION WERE INCLUDED IN THE STUDY. OUTCOMES AND NEUROLOGICAL EXAMINATIONS FROM BEFORE AND AFTER SURGERY WERE RETROSPECTIVELY EXAMINED FROM CLINIC NOTES. PERILESIONAL EDEMA WAS DETERMINED AT VARIOUS TIMEPOINTS USING VOLUMETRIC DATA DERIVED FROM MANUAL TRACINGS OF FLUID-ATTENUATED INVERSION RECOVERY (FLAIR) ENHANCEMENT ON MAGNETIC RESONANCE IMAGING (MRI). FINALLY, A LITERATURE REVIEW OF PRIOR CASES OF REPEAT LITT WAS PERFORMED. RESULTS: A TOTAL OF 9 PATIENTS UNDERWENT 18 TREATMENTS WITH LITT; ALL BUT 1 OF WHOM WERE TREATED FOR METASTATIC BRAIN LESIONS. ONE PATIENT HAD A TRANSIENT CEREBROSPINAL FLUID LEAK, WHEREAS A SECOND PATIENT HAD A SUPERFICIAL WOUND INFECTION, BOTH OF WHICH RESOLVED WITH STANDARD MEDICAL CARE. THE REMAINING 7 PATIENTS TOLERATED ALL LITT PROCEDURES WITHOUT COMPLICATION. ANALYSIS OF PERILESIONAL EDEMA VOLUME DEMONSTRATED A CORRELATION WITH THE AMOUNT OF ENERGY DELIVERED DURING LITT. LITERATURE REVIEW FOUND 5 PUBLISHED PAPERS DESCRIBING 9 PATIENTS WHO UNDERWENT LITT MORE THAN ONCE, THE MAJORITY OF WHOM TOLERATED REPEAT LITT WELL. CONCLUSION: LITT IS A SAFE AND PROMISING TREATMENT MODALITY AND MAY BE USED MULTIPLE TIMES WITHOUT ISSUE. THERE APPEARS TO BE AN ASSOCIATION BETWEEN THE AMOUNT OF ENERGY DELIVERED DURING A LITT SESSION AND THE DEGREE OF POSTOPERATIVE PERILESIONAL EDEMA. REPORTED EVENTS: ONE (B)(6) YEAR OLD FEMALE PATIENT EXPIRED 828 WEEKS FOLLOWING HER INITIAL LITT TREATMENT. ONE (B)(6) YEAR OLD FEMALE PATIENT WAS DECEASED AT THE TIME OF MEDICAL CHART REVIEW WITH UNKNOWN TIMING BETWEEN LITT AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566504 MEDTRONIC NAVIGATION LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death