BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE

    MDR report key: 11038331 · Received December 18, 2020

    Report

    Report Number
    1723170-2020-03329
    Event Type
    Injury
    Date Received
    December 18, 2020
    Date of Event
    June 1, 2013
    Report Date
    December 18, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE NOT AVAILABLE FROM THE SITE. PATIENT SEX NOT AVAILABLE FROM THE SITE. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE PUBLICATION DATE OF THE ABSTRACT. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. FACILITY AND ADDRESS NOT POPULATED AS THE FACILITY WAS NOT PROVIDED IN THE ABSTRACT PROVIDED. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CITATION: LASER ABLATION SURGERY FOR MESIAL TEMPORAL, LATERAL TEMPORAL, AND EXTRATEMPORAL FOCI WITH AND WITHOUT LESION; SUCCESSFUL INTEGRATION OF MSI, FMRI, AND EEG AND BRAINLAB TECHNOLOGY FOR NON-INVASIVE LOCALIZATION AND DESTRUCTION OF EPILEPTIC FOCI USING STEREOTACTIC LASER ABLATION (SLA) CHEZ M.; GHASSEMI A.; CIRICILLO S.; LEPAGE C.; SEKHON A.; LOW R.; SEMINARIO-LOPEZ N. EPILEPSIA (2013) 54 SUPPL. 3 (181). DATE OF PUBLICATION: JUNE 2013 PURPOSE: TO PRESENT A LESS INVASIVE TECHNIQUE FOR EPILEPSY SURGERY TREATMENT COMBINING SURFACE EEG, MSI (MAGNETIC SOURCE IMAGING) AND FMRI COMBINED WITH BRAINLAB LOCALIZATION TO ENABLE MINIMALLY INVASIVE MRI GUIDED STEREOTACTIC LASER ABLATION (SLA) OF EPILEPTOGENIC FOCI. METHOD: SIX CHILDREN AND 4-ADULTS WITH MEDICALLY REFRACTORY FOCAL EPILEPSY WERE EVALUATED WITH VIDEO EEG, 3-TESLA MRI, FMRI, MSI (9- PATIENTS) AND PET (1-PATIENT). TWO ADULTS HAD MESIAL TEMPORAL SCLEROSIS, THREE HAD FRONTAL FOCI, ONE HAD SUPERIOR NON-DOMINANT RIGHT SUPERIOR TEMPORAL GYRUS FOCUS, ONE HAD SUB-WERNICKES LEFT SUPERIOR-TEMPORAL GYRUS, ONE HAD DEEP LEFT CINGULATE GYRUS FOCUS NEAR THE POSTERIOR BODY OF THE CORPUS CALLOSUM, AND ONE EACH OF RIGHT AND LEFT OCCIPITAL/TEMPORAL/PARIETAL FOCI. THREE-PATIENTS REQUIRED 2-SEPARATE LASER PROBES TO BE PLACED, AND 1- PATIENT REQUIRED 3-LASER PROBES. TEN- PATIENTS HAD SLA (VISUALASE, INC.) WITH FRAMELESS NAVIGATION (BRAINLAB, INC.). ALL HAD INTRAOPERATIVE EEG MONITORING IN MRI USING PLASTIC ELECTRODES (IVES) PLACED OVER ABLATION REGION ON THE CRANIAL SURFACE BEFORE MRI GUIDANCE OF LASER ABLATION, THEREBY SHOWING PRE-ABLATION AND POST-ABLATION SPIKE DATA. PRE-PROCEDURE MSI SCANS WERE PERFORMED IN ALL PATIENTS: 9-PATIENTS VIA UCSF BIOMAGNETIC IMAGING CENTER, CTF SYSTEMS, AND 1- PATIENT VIA PET SCAN, NO MSI. PREOPERATIVE EEG MONITORING AND FMRI WAS DONE ON ALL PATIENTS. RESULTS: ALL PATIENTS SHOWED RESOLUTION (8) OR DIMINISHED NUMBER (2) OF PRE-ABLATION SPIKES ON INTRA-PROCEDURE EEG TAKEN IMMEDIATELY POST-ABLATION. SEVEN-PATIENTS WITH SINGLE OR MULTIPLE PROBE SLA WERE PAIN-FREE, EATING, AND AMBULATORY WITHIN 6-8 H POST-ABLATION AND DISCHARGED WITHIN 24-H. THREE-PATIENTS WERE DISCHARGED ON POST-SURGERY DAY 2. TO DATE, 2/3 FRONTAL, BOTH MESIAL TEMPORAL, BOTH OCCIPITAL, 1-CINGULATE, AND 1/2 LATERAL TEMPORAL LASER ABLATIONS REMAIN SEIZURE FREE. ONLY 1- MESIAL TEMPORAL PATIENT HAD A SUPERIOR QUANDRANTOPSIA. NINE OF TEN PARTICIPANTS HAVE NO KNOWN PERMANENT UNDESIRABLE SEQUELAE. IMPROVED EEG AND COGNITIVE FUNCTIONWAS NOTED AFTER FULL POST-OPERATIVE RECOVERY, CORRELATING WITH REDUCED SEIZURES. REPORTED EVENT(S): 1. ONE MESIAL-TEMPORAL PATIENT EXPERIENCED SUPERIOR QUANDRANTOPSIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503846 VISUALASE LASER INSTRUMENT, SURGICAL, POWERED GEX MEDTRONIC NAVIGATION, INC 9735542

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention