BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 9492384 · Received December 19, 2019

    Report

    Report Number
    1723170-2019-06089
    Event Type
    Injury
    Date Received
    December 19, 2019
    Date of Event
    October 1, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE IS AVERAGE AGE OF PATIENTS IN THE TREATMENT COHORT FOR THE ARTICLE. PATIENT GENDER IS THE MAJORITY GENDER OF PATIENTS IN THE TREATMENT COHORT FOR THE ARTICLE. DATE OF EVENT: 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. 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: BASSAGANYAS-VANCELLS, ET AL. ¿COMBINED USE OF 5-AMINOLEVULINIC ACID AND INTRAOPERATIVE LOW-FIELD MAGNETIC RESONANCE IMAGING IN HIGH-GRADE GLIOMA SURGERY.¿ WORLD NEUROSURGERY. OCT. 2019;130:E206-E212. HTTPS://DOI.ORG/10.1016/J.WNEU.2019.06.029 ABSTRACT: OBJECTIVE: WE SOUGHT TO ASSESS THE IMPACT OF 5-AMINOLEVULINIC ACID (5-ALA) AND LOW-FIELD INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IMRI) ON THE EXTENT OF RESECTION OF HIGH-GRADE GLIOMAS (HGGS). RESULTS ARE COMPARED WITH THOSE OBTAINED WHEN USING 5-ALA AND IMRI SEPARATELY. METHODS: WE RETROSPECTIVELY INCLUDED PATIENTS WITH AN HGG ELIGIBLE FOR GROSS TOTAL RESECTION (GTR) FROM JANUARY 2013 TO JANUARY 2018. PATIENTS WERE INCLUDED ACCORDING TO 5-ALA SURGICAL GUIDANCE (5A-GROUP), IMRI (IMRI-GROUP), OR BOTH (5A-IMRI-GROUP). SURGICAL VARIABLES WERE REGISTERED, AND PRESURGICAL AND POSTSURGICAL RADIOLOGIC AND CLINICAL VARIABLES WERE ANALYZED. EXTENT OF RESECTION GREATER OR EQUAL TO 90%, COMPLICATIONS, AND NEW PERMANENT NEUROLOGIC DEFICIT WERE COMPARED USING THE CHI-SQUARED AND ANALYSIS OF VARIANCE TESTS. OTHER VARIABLES STUDIED WERE MORTALITY, AVERAGE HOSPITAL STAY, SURGICAL TIME, AND KARNOFSKY PERFORMANCE SCALE STATUS BEFORE AND AFTER SURGERY. RESULTS: MOST OF THE 118 PROCEDURES CARRIED OUT WERE IN MEN (59.2%). THE MEAN AGE WAS 58 YEARS. SIXTY PATIENTS (50.8%) WERE OPERATED ON USING EXCLUSIVELY 5-ALA ASSISTANCE (5A-GROUP), 19 (16.1%) USING IMRI (IMRI-GROUP), AND 39 (33%) COMBINING BOTH TECHNIQUES (5A-IMRI-GROUP). THERE WERE NO STATISTICALLY SIGNIFICANT DIFFERENCES AMONG 3 GROUPS REGARDING EXTENT OF RESECTION GREATER OR EQUAL TO 90% (73% 5A, 73.7% IMRI, 71.8% 5A-IMRI, P = 0.94); COMPLICATION RATES (18.3% 5A, 5.3% IMRI, 7.7% 5A-IMRI, P = 0.17); NEW OR WORSENING OF PREEXISTING NEUROLOGIC DEFICIT AT 1-MONTH FOLLOW-UP (13.3% 5A, 10.5% IMRI, 15.4% 5A-IMRI, P = 0.26); AVERAGE HOSPITAL STAY IN DAYS (9.5 5A, 6.4 IMRI, 7.6 5A-IMRI, P = 0.18); KARNOFSKY PERFORMANCE SCALE; NOR SURGICAL TIME IN MINUTES (212.4 5A, 187.9 IMRI, 201.4 5A-IMRI, P = 0.13). CONCLUSIONS: IN OUR EXPERIENCE, COMBINED USE OF IMRI AND 5-ALA DOES NOT IMPROVE THE STUDIED VARIABLES WHEN COMPARED WITH THOSE TECHNOLOGIES WHEN USED SEPARATELY, EVEN THOUGH A SLIGHT TENDENCY OF A SUPERIOR EFFECTIVENESS IS OBSERVED WHEN USING IMRI INDIVIDUALLY. REPORTED EVENTS: 11 PATIENTS IN THE 5A-IMRI GROUP HAD RE-OPERATIONS. 8 PATIENTS IN THE 5A-IMRI GROUP HAD AN OCCURRENCE OF A NEW NEUROLOGIC DEFICIT OR WORSENING OF PREEXISTING DEFICIT IN THE IMMEDIATE POSTOPERATIVE PERIOD. 6 OF THESE PATIENTS HAD THESE DEFICITS REMAINING ONE MONTH POST-OPERATIVELY. 1 PATIENT IN THE 5A-IMRI GROUP HAD SUPERFICIAL INFECTION OF THE SURGICAL WOUND. 1 PATIENT IN THE 5A-IMRI GROUP HAD MENINGITIS (LISTERIA). 1 PATIENTS IN THE 5A-IMRI GROUP HAD AN EPIDURAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293858 MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other| R| S