BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 20727247 · Received November 19, 2024

    Report

    Report Number
    3004785967-2024-00725
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    January 1, 2021
    Report Date
    November 19, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A2) THIS VALUE REFLECTS THE MEDIAN AGE OF THE PATIENTS WHO UNDERWENT THE LASER INTERSTITIAL THERMAL THERAPY (LITT) AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT LITT AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ARTICLES PUBLISHED YEAR. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G2) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS UNAVAILABLE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    CITATION: VAZ DA SILVA, F., PINTO, V. S., SOUSA, S., SILVA, C., REIS, J., & CALHEIROS, A. (2021). LASER INTERSTITIAL THERMAL THERAPY WITH INTRAOPERATIVE O-ARM® NEURONAVIGATION IN MALIGNANT BRAIN TUMOURS ¿ CASE SERIES. BRAIN AND SPINE, 1, 100543. HTTPS://DOI.ORG/10.101 6/J.BAS.2021.100543 ABSTRACT: SCIENTIFIC EVIDENCE FOR LASER INTERSTITIAL THERMAL THERAPY (LITT) AS TREATMENT OPTION FOR MALIGNANT BRAIN TUMOURS (MBT) IS INCREASING. LITT CAN BE PERFORMED WITH INTRAOPERATIVE O-ARM® NEURONAVIGATION (OLITT). CURRENTLY THERE ARE NO CASE SERIES PUBLISHED USING OLITT. FOUR CASES OF OLITT WERE PERFORMED FROM DECEMBER 2019 TO OCTOBER 2020 IN A SINGLE NEUROSURGERY CENTER. PATIENTS SELECTED FOR OLITT WEREN¿T CANDIDATES TO SURGICAL OR CHEMORADIOTHERAPY TREATMENT, HAD INADEQUATE ANESTHETIC CONDITIONS OR POOR FUNCTIONAL STATUS. MEDIAN AGE OF PATIENTS WAS 65 15.85 (42-76) YEARS OLD AND THREE WERE FEMALE. OLITT WAS PERFORMED IN TWO PATIENTS WITH GLIOBLASTOMA (CASE 1:RIGHT FRONTAL RECURRENCE, 23 MONTHS AFTER THE INITIAL RIGHT TEMPORAL LESION DIAGNOSIS; CASE 2:NEWLY DIAGNOSED RIGHT LESION NEAR CENTRAL SULCUS SUBMITTED TO NEURONAVIGATION ASSISTED BIOPSY PREVIOUSLY IN THE SAME PROCEDURE), ONE PATIENT WITH LOCAL RECURRENCE OF A LEFT PARIETAL ANAPLASIC OLIGODENDROGLIOMA, 86 MONTHS AFTER DIAGNOSIS (CASE 3) AND ONE PATIENT WITH CLINICAL DETERIORATION AND IMAGIOLOGIC PROGRESSION OF RADIONECROSIS AFTER RADIOTHERAPY FOR A LEFT CEREBELLAR PEDUNCLE METASTASIS, 30 MONTHS AFTER DIAGNOSIS (CASE 4). A SINGLE CATHETER WAS USED FOR THERMOABLATION WITH TRAJECTORY ERROR 3MM, EXCEPT IN CASE 2 WHERE TWO CATHETERS WERE USED AND ONE HAD TRAJECTORY ERROR OF 8MM. ABLATION OF TOTAL LESION VOLUME WAS ACHIEVED IN ALL CASES EXCEPTIN CASE 2 (90%). IN CASE 1, CRANIOTOMY WAS PERFORMED AT 11 MONTHS AFTER OLITT DUE TO LOCAL RECURRENCE. IN CASE 2, A SMALL PERILESION HEMORRHAGE OCCURRED DURING PROCEDURE AND MOTOR DEFICIT GOT WORSE. THE PATIENT DIED 1 MONTH AFTER OLITT DUE TO COVID-19. IN CASES 3 AND 4, LESION VOLUME WAS LOWER AND NO PROGRESSION WAS NOTICED AT 15 MONTH FOLLOW-UP. LITT IS A VALID THERAPEUTIC OPTION FOR PATIENTS WITH MBT WHO AREN¿T SURGICAL OR CHEMORADIOTHERAPY CANDIDATES AND WHEN NO OTHER COMPLEMENTARY TREATMENT OPTIONS ARE AVAILABLE, INCREASING PROGRESSION-FREE AND OVERALL SURVIVAL. REPORTED EVENT: FOUR PATIENTS UNDERWENT LASER INTERSTITIAL THERMAL THERAPY (LITT) AS TREATMENT OPTION FOR MALIGNANT BRAIN TUMOURS. A SINGLE CATHETER WAS USED FOR THERMOABLATION WITH TRAJECTORY ERROR OF LESS THAN OR EQUAL TO 3MM, EXCEPT IN CASE 2 WHERE TWO CATHETERS WERE USED AND ONE HAD TRAJECTORY ERROR OF 8MM. A SMALL PERILESION HEMORRHAGE OCCURRED AND MOTOR DEFICIT GOT WORSE. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009342 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female