BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17501969 · Received August 10, 2023

    Report

    Report Number
    1723170-2023-01439
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    January 1, 2022
    Report Date
    August 10, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN DENMARK, 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.

    Description of Event or Problem · 0

    CITATION: NEUROSURG CLIN N AM 34 (2023) 239-245 HTTPS://DOI.ORG/10.1016/J.NEC.2022.11 .003. SUMMARY: KEY POINTS: LASER INTERSTITIAL THERMAL THERAPY (LITT) IN THE AWAKE PATIENT IS FEASIBLE AND SAFE. CONTINUOUS NEUROLOGIC EVALUATION DURING LASER ABLATION CAN GUIDE PERIOPERATIVE DECISIONS. IN OUR EXPERIENCE, THE AWAKE LITT WORKFLOW IS VALUABLE IN ACHIEVING MAXIMAL SAFE ABLATION. IF NO INVOLVEMENT OF DURA MATER, THE PATIENT FEELS NO PAIN DURING LASER ABLATION. REPORTED EVENT: THIS WAS A CASE STUDY OF A 28 YEAR OLD FEMALE. AFTER THE FIRST OPERATION, SHE SUFFERED FROM A MILD LEFT-SIDED FACIAL PALSY AND LESS VISUAL ATTENTION TO THE LEFT. SHE HAD LEFT-SIDED FOCAL SEIZURES AND SOME GENERALIZED SEIZURES. DURING THE FINAL ABLATION, THE PATIENT HAD WORSENING OF HER PREEXISTING FACIAL PALSY, AND FURTHER TREATMENT WAS ABORTED. POSTOPERATIVELY, SHE CONTINUED TO HAVE A DISCRETE WORSENING OF THE FACIAL PALSY. DURING THE FOLLOWING WEEKS, THE PALSY GRADUALLY REMITTED. HOWEVER, IN THE FOLLOWING MONTHS AFTER TREATMENT, SHE EXPERIENCED INTERMITTENT HEADACHE AND TIREDNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1062872 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention| H