BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 12435939 · Received September 7, 2021

    Report

    Report Number
    1723170-2021-02215
    Event Type
    Injury
    Date Received
    September 7, 2021
    Date of Event
    June 24, 2020
    Report Date
    September 7, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ARTICLE. THIS VALUE REFLECTS THE MEAN AGE OF PATIENTS IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY 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 ACCEPTED AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. ARTICLE CITATION IS INCLUDED. SYSTEM PRODUCT NUMBER AND SERIAL NUMBER NOT PROVIDED IN JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. 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: GUPTA K, CABANISS B, KHEDER A, ET AL. STEREOTACTIC MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY FOR EXTRATEMPORAL LOBE EPILEPSY. EPILEPSIA. 2020;61:1723¿1734. HTTPS://DOI.ORG/10.1111/EPI.16614 SUMMARY: OBJECTIVE: MAGNETIC RESONANCE IMAGING (MRI)¿GUIDED LASER INTERSTITIAL THERMAL THERAPY (MRG-LITT) IS AN ALTERNATIVE TO OPEN EPILEPSY SURGERY. WE ASSESS SAFETY AND EFFECTIVENESS OF MRG-LITT FOR EXTRATEMPORAL LOBE EPILEPSY (ETLE) IN PATIENTS WHO ARE CONSIDERED LESS FAVORABLE FOR OPEN RESECTION. METHODS: WE RETROSPECTIVELY REVIEWED SEQUENTIAL CASES OF PATIENTS WITH FOCAL ETLE WHO UNDERWENT MRG-LITT BETWEEN 2012 AND 2019. EPILEPTOGENIC ZONES WERE DETERMINED FROM STANDARD CLINICAL AND IMAGING DATA ± STEREOELECTROENCEPHALOGRAPHY (SEEG). STANDARD STEREOTACTIC TECHNIQUES, MRI THERMOMETRY, AND A COMMERCIAL LASER THERMAL THERAPY SYSTEM WERE USED FOR ABLATIONS. ANATOMIC MRI WAS USED TO CALCULATE ABLATION VOLUMES. CLINICAL OUTCOMES WERE DETERMINED LONGITUDINALLY. RESULTS: THIRTY-FIVE PATIENTS WITH MEAN EPILEPSY DURATION OF 21.3 ± 12.2 YEARS UNDERWENT MRG-LITT FOR FOCAL ETLE AT A MEAN AGE 36.4 ± 12.7 YEARS. A MEAN 2.59 ± 1.45 TRAJECTORIES PER PATIENT WERE USED TO OBTAIN ABLATION VOLUMES OF 8.8 ± 7.5 CM3. MEAN FOLLOW-UP WAS 27.3 ± 19.5 MONTHS. OF 32 PATIENTS WITH >12 MONTHS OF FOLLOW-UP, 17 (53%) ACHIEVED GOOD OUTCOMES (ENGEL CLASS I + II) OF WHOM 14 (44%) WERE ENGEL CLASS I. SUBGROUP ANALYSIS REVEALED BETTER OUTCOMES FOR PATIENTS WITH LESIONAL ETLE THAN FOR THOSE WHO WERE NONLESIONAL, MULTIFOCAL, OR WHO HAD FAILED PRIOR INTERVENTIONS (P = .02). OF 13 PATIENTS SHOWING FAVORABLE SEIZURE-ONSET PATTERNS (LOCALIZED LOW VOLTAGE FAST ACTIVITY OR RHYTHMIC SPIKING ON SEEG) PRIOR TO ABLATION, 9 (69%) ACHIEVED GOOD OUTCOMES, WHEREAS ONLY 3 OF 11 (27%) WHO SHOW OTHER SLOWER ONSET PATTERNS ACHIEVED GOOD OUTCOMES. MINOR ADVERSE EVENTS INCLUDED SIX PATIENTS WITH TRANSIENT SENSORIMOTOR NEUROLOGIC DEFICITS AND FOUR PATIENTS WITH ASYMPTOMATIC HEMORRHAGES ALONG THE FIBER TRACT. MAJOR ADVERSE EVENTS INCLUDED ONE PATIENT WITH A BRAIN ABSCESS THAT REQUIRED STEREOTACTIC DRAINAGE AND ONE PATIENT WITH PERSISTENT HYPOTHALAMIC OBESITY. THREE DEATHS¿TWO SEIZURE-ASSOCIATED AND ONE SUICIDE¿WERE UNRELATED TO SURGICAL PROCEDURES. REPORTED EVENTS: FOUR PATIENTS EXPERIENCED ASYMPTOMATIC TRACT HEMORRHAGE ON IMAGING DURING THE COURSE OF THE SURGERY THAT DID NOT REQUIRE ANY INTERVENTION OR IMPACT HOSPITAL LENGTH OF STAY. THE TOTAL RATE OF PROCEDURE-RELATED INTRACRANIAL HEMORRHAGES WAS 4 OF 35 (11%); NONE CAUSED DEFICITS OR REQUIRED SURGICAL INTERVENTION. ONE MALE PATIENT EXPERIENCED SURGICAL READMISSION FOR AN INTRACRANIAL ABSCESS AT THE SITE OF ABLATION. HE HAD ALREADY UNDERGONE THREE RIGHT CRANIOTOMIES FOR SDE GRID-BASED EVALUATION AND RIGHT TEMPORAL LOBECTOMY. HE DID NOT MAINTAIN LONG-TERM SEIZURE FREEDOM AND 3 YEARS LATER UNDERWENT SEEG REINVESTIGATION, WHICH REVEALED AN EZ INVOLVING RIGHT RETROSPLENIAL CINGULATE, POSTERIOR CINGULATE, AND POSTERIOR PARAHIPPOCAMPAL CORTICES. SIX MONTHS LATER HE UNDERWENT LASER ABLATION OF THE RIGHT RETROSPENIAL/POSTERIOR CINGULATE AND POSTERIOR PARAHIPPOCAMPAL CORTICES WITH THREE DE NOVO LASER BOLT TRAJECTORIES PLACED BY STEREOTACTIC ROBOT. NOTABLY, ONE SUCH BOLT WAS PLACED THROUGH A PRIOR CRANIOTOMY SCAR NEAR THE VERTEX. HE PRESENTED 4 WEEKS LATER WITH ALTERED MENTAL STATUS AND SUPERFICIAL DRAINAGE FROM THIS SPECIFIC SITE. DIFFUSION AND CONTRASTED MRI SUGGESTED A BRAIN ABSCESS INVOLVING THE ABLATION SITE AND STEREOTACTIC TRACT WITH SURROUNDING VASOGENIC EDEMA. INCISION THROUGH VASCULARLY COMPROMISED SCALP AND POOR HEALING WAS FELT TO BE A RISK FACTOR FOR INFECTION. HE UNDERWENT STEREOTACTIC NEEDLE ASPIRATION AND A COURSE OF INTRAVENOUS ANTIBIOTICS, RECOVERED WITHOUT LONG-TERM SEQUELAE, AND HAD EXCELLENT SEIZURE CONTROL. FIVE PATIENTS EXPERIENCED MEDICAL READMISSION. ONE PATIENT WHO WAS ABLATED IN THE CONTEXT OF PALLIATIVE TREATMENT OF STATUS EPILEPTICUS, HAD AN EXTENDED POSTOPERATIVE HOSPITALIZATION FOR MEDICAL MANAGEMENT OF HYPONATREMIA. SIX PATIENTS (17%) WERE READMITTED PERIOPERATIVELY FOR VARIOUS REASONS INCLUDING INFECTION, SEIZURES, POSTOPERATIVE HEADACHES, MEDICATION ENCEPHALOPATHY AND TRANSIENT VAGUE COMPLAINTS, AND INITIATION OF ANTICOAGULATION FOR NEW DIAGNOSIS OF DEEP VEIN THROMBOSIS. ONE PATIENT WHO HAD A PRIOR HISTORY OF DEEP VEIN THROMBOSIS AND CHRONIC ANTICOAGULATION, WAS READMITTED BRIEFLY FOR A DELAYED ANTICOAGULATION ASSOCIATED SYMPTOMATIC SUBDURAL HEMATOMA AT A PREVIOUS OPERATIVE SITE THAT WAS SUCCESSFULLY MANAGED NONOPERATIVELY. ONE PATIENT EXPERIENCED PERSISTENT DEFICIT OF HYPOTHALAMIC OBESITY SEE ATTACHED ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331799 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention