BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 17548668 · Received August 15, 2023

    Report

    Report Number
    1723170-2023-01463
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    March 3, 2023
    Report Date
    August 15, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 MEAN AGE OF THE PATIENTS WHO UNDERWENT THE STEREOTACTIC LASER ABLATION AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE STEREOTACTIC LASER ABLATION AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED 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. DIGITAL SHARING OF THE ARTICLE WOULD BE IN VIOLATION OF COPYRIGHT PERMISSION. 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: AROCHO-QUINONES, E. V., LEW, S. M., HANDLER, M. H., TOVAR-SPINOZA, Z., SMYTH, M. D., BOLLO, R. J., DONAHUE, D., PERRY, M. S., LEVY, M., GONDA, D., MANGANO, F. T., KENNEDY, B. C., STORM, P. B., PRICE, A. V., COUTURE, D. E., OLUIGBO, C., DUHAIME, A.-C., BARNETT, G. H., MUH, C. R., ¿ __. (2023). MAGNETIC RESONANCE IMAGING¿GUIDED STEREOTACTIC LASER ABLATION THERAPY FOR THE TREATMENT OF PEDIATRIC EPILEPSY: A RETROSPECTIVE MULTIINSTITUTIONAL STUDY. JOURNAL OF NEUROSURGERY: PEDIATRICS, 1¿14. HTTPS://DOI.ORG/10.3171/2022.12.PEDS22282 SUMMARY: OBJECTIVE: THE AUTHORS OF THIS STUDY EVALUATED THE SAFETY AND EFFICACY OF STEREOTACTIC LASER ABLATION (SLA) FOR THE TREATMENT OF DRUG-RESISTANT EPILEPSY (DRE) IN CHILDREN. METHODS: SEVENTEEN NORTH AMERICAN CENTERS WERE ENROLLED IN THE STUDY. DATA FOR PEDIATRIC PATIENTS WITH DRE WHO HAD BEEN TREATED WITH SLA BETWEEN 2008 AND 2018 WERE RETROSPECTIVELY REVIEWED. RESULTS: A TOTAL OF 225 PATIENTS, MEAN AGE 12.8 ± 5.8 YEARS, WERE IDENTIFIED. TARGET-OF-INTEREST (TOI) LOCATIONS INCLUDED EXTRATEMPORAL (44.4%), TEMPORAL NEOCORTICAL (8.4%), MESIOTEMPORAL (23.1%), HYPOTHALAMIC (14.2%), AND CALLOSAL (9.8%). VISUALASE AND NEUROBLATE SLA SYSTEMS WERE USED IN 199 AND 26 CASES, RESPECTIVELY. PROCEDURE GOALS INCLUDED ABLATION (149 CASES), DISCONNECTION (63), OR BOTH (13). THE MEAN FOLLOW-UP WAS 27 ± 20.4 MONTHS. IMPROVEMENT IN TARGETED SEIZURE TYPE (TST) WAS SEEN IN 179 (84.0%) PATIENTS. ENGEL CLASSIFICATION WAS REPORTED FOR 167 (74.2%) PATIENTS; EXCLUDING THE PALLIATIVE CASES, 74 (49.7%), 35 (23.5%), 10 (6.7%), AND 30 (20.1%) PATIENTS HAD ENGEL CLASS I, II, III, AND IV OUTCOMES, RESPECTIVELY. FOR PATIENTS WITH A FOLLOW-UP = 12 MONTHS, 25 (51.0%), 18 (36.7%), 3 (6.1%), AND 3 (6.1%) HAD ENGEL CLASS I, II, III, AND IV OUTCOMES, RESPECTIVELY. PATIENTS WITH A HISTORY OF PRE-SLA SURGERY RELATED TO THE TOI, A PATHOLOGY OF MALFORMATION OF CORTICAL DEVELOPMENT, AND 2+ TRAJECTORIES PER TOI WERE MORE LIKELY TO EXPERIENCE NO IMPROVEMENT IN SEIZURE FREQUENCY AND/OR TO HAVE AN UNFAVORABLE OUTCOME. A GREATER NUMBER OF SMALLER THERMAL LESIONS WAS ASSOCIATED WITH GREATER IMPROVEMENT IN TST. THIRTY (13.3%) PATIENTS EXPERIENCED 51 SHORT-TERM COMPLICATIONS INCLUDING MALPOSITIONED CATHETER (3 CASES), INTRACRANIAL HEMORRHAGE (2), TRANSIENT NEUROLOGICAL DEFICIT (19), PERMANENT NEUROLOGICAL DEFICIT (3), SYMPTOMATIC PERILESIONAL EDEMA (6), HYDROCEPHALUS (1), CSF LEAKAGE (1), WOUND INFECTION (2), UNPLANNED ICU STAY (5), AND UNPLANNED 30-DAY READMISSION (9). THE RELATIVE INCIDENCE OF COMPLICATIONS WAS HIGHER IN THE HYPOTHALAMIC TARGET LOCATION. TARGET VOLUME, NUMBER OF LASER TRAJECTORIES, NUMBER OR SIZE OF THERMAL LESIONS, OR USE OF PERIOPERATIVE STEROIDS DID NOT HAVE A SIGNIFICANT EFFECT ON SHORT-TERM COMPLICATIONS. CONCLUSIONS: SLA APPEARS TO BE AN EFFECTIVE AND WELL-TOLERATED TREATMENT OPTION FOR CHILDREN WITH DRE. LARGE-VOLUME PROSPECTIVE STUDIES ARE NEEDED TO BETTER UNDERSTAND THE INDICATIONS FOR TREATMENT AND DEMONSTRATE THE LONG-TERM EFFICACY OF SLA IN THIS POPULATION. REPORTED EVENT: 16. INTRAOPERATIVELY THREE PATIENTS EXPERIENCED MISPOSITIONED CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1793767 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Male Other