BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12592922 · Received October 7, 2021

    Report

    Report Number
    1723170-2021-02457
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    April 21, 2021
    Report Date
    October 7, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE REFLECTS THE MEDIAN AGE OF THE PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS PUBLISHED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. NO EVALUATION WAS PERFORMED AS THIS EVENT WAS REPORTED IN LITERATURE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: TAO JX, SATZER D, ISSA NP, ET AL. STEREOTACTIC LASER ANTERIOR CORPUS CALLOSOTOMY FOR LENNOX-GASTAUT SYNDROME. EPILEPSIA. 2020;61:1190¿1200. HTTPS://DOI.ORG/10.1111/EPI.16535 SUMMARY: OBJECTIVE: CORPUS CALLOSOTOMY IS AN EFFECTIVE PALLIATIVE TREATMENT FOR DRUG-RESISTANT LENNOX-GASTAUT SYNDROME (LGS). LASER INTERSTITIAL THERMAL THERAPY HAS BEEN INCREASINGLY USED IN THE TREATMENT OF EPILEPSY. HERE, WE ASSESS THE SAFETY AND EFFECTIVENESS OF MINIMALLY INVASIVE STEREOTACTIC LASER ANTERIOR CORPUS CALLOSOTOMY (SLACC) FOR DROP ATTACKS IN LGS. METHODS: WE REVIEWED SEQUENTIAL CASES OF PATIENTS WITH MEDICALLY INTRACTABLE LGS WHO UNDERWENT SLACC USING A TWO-CANNULA TECHNIQUE BETWEEN NOVEMBER 2014 AND JULY 2019. PRE- AND POSTOPERATIVE MAGNETIC RESONANCE IMAGING WAS USED TO MEASURE THE ANTEROPOSTERIOR LENGTH OF CALLOSAL ABLATION (CONTRAST-ENHANCING LESION) AND ESTIMATED DISCONNECTION (GAP IN TRACT PROJECTIONS ON DIFFUSION TENSOR IMAGING). PATIENTS WERE FOLLOWED LONGITUDINALLY TO ASSESS CLINICAL OUTCOMES. RESULTS: TEN PATIENTS WERE INCLUDED IN THIS STUDY. THE MEDIAN AGE WAS 33 (RANGE = 11-52) YEARS, MEDIAN DURATION OF EPILEPSY WAS 26 (RANGE = 10-49) YEARS, AND MEDIAN DURATION OF POSTOPERATIVE FOLLOW-UP WAS 19 (RANGE = 6-40) MONTHS. IN THE ANTEROPOSTERIOR DIRECTION, 53 ± 7% (MEAN ± SD) OF THE CORPUS CALLOSUM WAS ABLATED AND 62 ± 19% OF THE CORPUS CALLOSUM WAS ESTIMATED TO BE DISCONNECTED. SIX (60%) OF 10 PATIENTS ACHIEVED >80% SEIZURE REDUCTION, TWO (20%) OF WHOM BECAME SEIZURE-FREE. EIGHT (80%) PATIENTS HAD >80% REDUCTION IN DROP ATTACKS, FIVE (50%) OF WHOM BECAME FREE OF DROP ATTACKS. THREE PATIENTS SUBSEQUENTLY UNDERWENT LASER POSTERIOR CALLOSOTOMY WITH FURTHER IMPROVEMENT IN DROP ATTACKS AND/OR OVERALL SEIZURE FREQUENCY. ONE PATIENT HAD AN ASYMPTOMATIC INTRACEREBRAL HEMORRHAGE ALONG THE CANNULA TRACT. ONE PATIENT DEVELOPED SIGNIFICANT AGGRESSION AFTER BECOMING SEIZURE-FREE. SIGNIFICANCE: SEIZURE OUTCOMES FOLLOWING SLACC WERE COMPARABLE TO PREVIOUSLY REPORTED OUTCOMES OF OPEN CALLOSOTOMY, WITH REASONABLE SAFETY PROFILE. SLACC APPEARS TO BE AN EFFECTIVE ALTERNATIVE TO OPEN ANTERIOR CORPUS CALLOSOTOMY WITH MINIMAL POSTOPERATIVE DISCOMFORT AND A SHORT RECOVERY PERIOD. REPORTED EVENTS: 1. ONE PATIENT HAD A 13-ML PARIETAL INTRACEREBRAL HEMORRHAGE NEAR A CANNULA ENTRY SITE. THE HEMORRHAGE WAS CLINICAL ASYMPTOMATIC WITH NO FOCAL DEFICIT OR REPORTED FUNCTIONAL IMPAIRMENT. SEE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488118 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other