BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17548526 · Received August 15, 2023

    Report

    Report Number
    1723170-2023-01460
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    April 14, 2023
    Report Date
    August 15, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    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 MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL ABLATION (MRGLITT) AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL ABLATION (MRGLITT) AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE PUBLISHED DATE. 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 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    CITATION: RAVINDRA, V. M., RUGGIERI, L., GADGIL, N., ADDISON, A. P., PATINO, I., GONDA, D. D., CHU, J., WHITEHEAD, L., ANDERSON, A., DIAZ-MEDINA, G., HOUCK, K., KATYAYAN, A., MASTERS, L., NATH, A., QUACH, M., RIVIELLO, J. J., SETO, E., SULLY, K. E., AGURS, L., ¿ CURRY, D. J. (2023). AN INITIAL EXPERIENCE OF COMPLETION HEMISPHEROTOMY VIA MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERAPY. STEREOTACTIC AND FUNCTIONAL NEUROSURGERY, 101(3), 179¿187. HTTPS://DOI.ORG/10.1159/000528452 SUMMARY: INTRODUCTION: IN CAREFULLY SELECTED PATIENTS WITH MEDICALLY REFRACTORY EPILEPSY, DISCONNECTIVE HEMISPHEROTOMY CAN RESULT IN SIGNIFICANT SEIZURE FREEDOM; HOWEVER, INCOMPLETE DISCONNECTION CAN RESULT IN ONGOING SEIZURES AND POSES A SIGNIFICANT CHALLENGE. COMPLETION HEMISPHEROTOMY PROVIDES AN OPPORTUNITY TO FINISH THE DISCONNECTION. WE DESCRIBE THE USE OF MAGNETIC RESONANCE-GUIDED LASER INTERSTITIAL THERMAL ABLATION (MRGLITT) FOR COMPLETION HEMISPHEROTOMY. METHODS: PATIENTS TREATED WITH COMPLETION HEMISPHEROTOMY USING MRGLITT AT OUR INSTITUTION WERE IDENTIFIED. PROCEDURAL AND SEIZURE OUTCOMES WERE EVALUATED RETROSPECTIVELY. RESULTS: FIVE PATIENTS (3 MALES) UNDERWENT SIX MRGLITT PROCEDURES (ONE CHILD TREATED TWICE) FOR COMPLETION HEMISPHEROTOMY AT A MEDIAN AGE OF 6 YEARS (RANGE 1.8¿12.9). TWO CHILDREN HAD HEMIMEGALENCEPHALY, TWO HAD RASMUSSEN ENCEPHALITIS, AND ONE HAD POLYMICROGYRIA. ALL FIVE CHILDREN HAD PERSISTENT SEIZURES LIKELY SECONDARY TO INCOMPLETE DISCONNECTION AFTER THEIR FUNCTIONAL HEMISPHEROTOMY. THE MEAN TIME FROM OPEN HEMISPHEROTOMY TO MRGLITT WAS 569.5 ± 272.4 DAYS (MEDIAN 424, RANGE 342¿1,095). ONE PATIENT UNDERWENT STEREOELECTROENCEPHALOGRAPHY BEFORE MRGLITT. THE MEAN NUMBER OF ABLATION TARGETS WAS 2.3 ± 0.47 (MEDIAN 2 ,RANGE 2¿3). THE MEAN LENGTH OF THE PROCEDURE WAS 373 MIN ± 68.9 (MEDIAN 374, RANGE 246¿475). FOUR OF THE FIVE PATIENTS WERE AFFORDED IMPROVEMENT IN THEIR NEUROCOGNITIVE FUNCTIONING AND SPEECH PERFORMANCE AFTER ABLATION, WITH MEAN DAILY SEIZURE FREQUENCY AT 1 YEAR OF 1.03 ± 1.98 (MEDIAN 0, RANGE 0¿5). TWO PATIENTS ACHIEVED ENGEL CLASS I OUTCOMES AT 1 YEAR AFTER ABLATION, ONE WAS ENGEL CLASS III, AND TWO WERE ENGEL CLASS IV. THE MEAN FOLLOW-UP TIME WAS 646.8 ± 179.5 DAYS (MEDIAN 634, RANGE 384¿918). NO MRGLITT-RELATED COMPLICATIONS OCCURRED. DELAYED RETREATMENT (>1 YEAR) OCCURRED IN THREE PATIENTS: ONE CHILD UNDERWENT REDO ABLATION AND TWO UNDERWENT ANATOMIC HEMISPHERECTOMY. CONCLUSIONS: WE HAVE DEMONSTRATED THE FEASIBILITY OF A MINIMALLY INVASIVE APPROACH FOR COMPLETION HEMISPHEROTOMY USING MRGLITT. DELAYED RETREATMENT WAS NEEDED IN THREE PATIENTS; THUS, FURTHER STUDY OF THIS TECHNIQUE WITH COMPARISON TO OTHER SURGICAL TECHNIQUES IS WARRANTED. REPORTED EVENT: 1. THREE PATIENTS NEEDED ADDITIONAL TREATMENT AFTER THE MRGLITT. 2. ONE PATIENT REQUIRED A VENTRICULAR TO PERITONEAL SHUNT PLACEMENT. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994447 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Other