BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17018579 · Received May 30, 2023

    Report

    Report Number
    1723170-2023-00867
    Event Type
    Injury
    Date Received
    May 30, 2023
    Date of Event
    December 3, 2022
    Report Date
    May 30, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN SWEDEN, SEE E1-E3. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: NEUROSURG CLIN N AM 34 (2023) 259-267 HTTPS://DOI.ORG/10.1016/J.NEC.2022.12.003 SUMMARY: IN THIS CONSECUTIVE, SINGLE-INSTITUTION SERIES OF THE INITIAL 30 PATIENTS TREATED WITH STEREOTACTIC LASER ABLATION (SLA) WE SHOW THAT SLA IS A MINIMALLY INVASIVE PROCEDURE WITH FEW ADVERSE EVENTS. OUR RESULTS SHOW AN IMPROVEMENT OF PRECISION OF THE LASER CATHETER PLACEMENT AND LESION COVERAGE OVER TIME INDICATING A LEARNING CURVE. FOUR PATIENTS (13.3%) EXPERIENCED NEW NEUROLOGICAL DEFICITS, WHEREAS ONLY ONE PATIENT HAD PERMANENT NEUROLOGICAL DEFICITS. REPORTED EVENT(S): THIS WAS A RETROSPECTIVE STUDY. THERE WERE 30 PATIENTS INCLUDED. THERE WERE 12 FEMALES AND 18 MALES, AND THE PATIENTS' AGES RANGED FROM 33-56 WITH AN AVERAGE AGE OF 48 YEARS. ELEVEN PATIENTS EXPERIENCED AN ADVERSE EVENT. HYPERTHERMIC COMPLICATIONS OCCURRED WITH THREE PATIENTS, TWO OF WHICH WERE LIKELY THE RESULT OF INADEQUATE IRRIGATION. ONE PATIENT EXPERIENCED A SMALL, SUBCLINICAL, HYPERINTENSE LESION THAT OCCURRED ON THE MRI. WITH ANOTHER PATIENT THERE WAS A TECHNICAL COMPLICATION WITH LEAKAGE AT THE IRRIGATION CONNECTION SITE, RESULTING IN AN INADEQUATE COOLING OF THE LASER CATHETER DURING A PART OF THE TREATMENT. THE PROCEDURE WAS ABORTED HALF-WAY THROUGH AS A RESULT, AND IT WAS NOTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT RELATED TO THIS ISSUE. THERE WAS INADEQUATE COOLING FOR A SHORT PERIOD OF TIME. ANOTHER PATIENT EXPERIENCED A TEMPORARY HYPOTHALAMIC DISTURBANCE. THREE PATIENTS EXPERIENCED WOUND INFECTIONS REQUIRING DEBRIDEMENT. FOUR PATIENTS SUFFERED FROM NEW NEUROLOGICAL DEFICITS (ONE PATIENT HAD DIFFICULTIES WITH FINE MOTOR SKILLS OF THE RIGHT HAND, TWO PATIENTS EXPERIENCED TEMPORARY SPEECH DISTURBANCES AND ONE PATIENT HAD A PERMANENT HEMIPARES IS ALTHOUGH IMPROVING FORM INITIAL HEMIPLEGIA AFTER TREATMENT). THREE PATIENTS HAD SOME SIGNS OF SURGICAL SITE INFECTION, ALTHOUGH ONLY ONE PATIENT HAD TO UNDERGO SURGICAL DEBRIDEMENT USING GENERAL ANESTHESIA. ONE PATIENT EXPERIENCED BURNING ON THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849135 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization| R