BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISUALASE SYSTEM

    MDR report key: 15235130 · Received August 16, 2022

    Report

    Report Number
    1723170-2022-01309
    Event Type
    Injury
    Date Received
    August 16, 2022
    Date of Event
    October 29, 2021
    Report Date
    August 16, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGE: PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. SEX: PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. WEIGHT: PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. DATE OF EVENT: EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. UDI #: DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. PMA/510K: 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, UNAVAILABLE. 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 · 0

    SATZER, D., MAHAVADI, A., LACY, M., GRANT, J.E., WARNKE, P. INTERSTITIAL LASER ANTERIOR CAPSULOTOMY FOR OBSESSIVE¿ COMPULSIVE DISORDER: LESION SIZE AND TRACTOGRAPHY CORRELATE WITH OUTCOME. J NEUROL NEUROSURG PSYCHIATRY. 2022. 93 (317¿323) DOI:10.1136/JNNP-2021-327730 BACKGROUND: ANTERIOR CAPSULOTOMY IS A WELL-ESTABLISHED TREATMENT FOR REFRACTORY OBSESSIVE¿COMPULSIVE DISORDER (OCD). MRI-GUIDED LASER INTERSTITIAL THERMAL THERAPY (LITT) ALLOWS CREATION OF LARGE, SHARPLY DEMARCATED LESIONS WITH THE SAFEGUARD OF REAL-TIME IMAGING. OBJECTIVE: TO CHARACTERISE THE OUTCOMES OF LASER ANTERIOR CAPSULOTOMY, INCLUDING RADIOGRAPHICAL PREDICTORS OF IMPROVEMENT. METHODS: PATIENTS WITH SEVERE OCD REFRACTORY TO PHARMACOTHERAPY AND COGNITIVE¿BEHAVIOURAL THERAPY UNDERWENT BILATERAL ANTERIOR CAPSULOTOMY VIA LITT. THE PRIMARY OUTCOME WAS PER CENT REDUCTION IN YALEBROWN OBSESSIVE¿COMPULSIVE SCALE (Y-BOCS) SCORE OVER TIME. LESION SIZE WAS MEASURED ON POSTABLATION MRI. DISCONNECTION OF THE ANTERIOR LIMB OF THE INTERNAL CAPSULE (ALIC) WAS ASSESSED VIA INDIVIDUAL AND NORMATIVE TRACTOGRAPHY. RESULTS: EIGHTEEN PATIENTS UNDERWENT LASER ANTERIOR CAPSULOTOMY. MEDIAN FOLLOW-UP WAS 6 MONTHS (RANGE 3¿51 MONTHS). TIME OCCUPIED BY OBSESSIONS IMPROVED IMMEDIATELY (MEDIAN Y-BOCS ITEM 1 SCORE 4¿1, P=0.002). MEAN (±SD) DECREASE IN Y-BOCS SCORE AT LAST FOLLOW-UP WAS 46%±32% (16±11 POINTS, P 0.0001). SIXTY-ONE PER CENT OF PATIENTS WERE RESPONDERS. SEVEN PATIENTS (39%) EXHIBITED TRANSIENT POSTOPERATIVE APATHY. ONE PATIENT HAD AN ASYMPTOMATIC INTRACEREBRAL HAEMORRHAGE. REDUCTION IN Y-BOCS SCORE WAS POSITIVELY ASSOCIATED WITH ABLATION VOLUME (P=0.006). INDIVIDUAL TRACTOGRAPHY DEMONSTRATED DURABLE ALIC DISCONNECTION. NORMATIVE TRACTOGRAPHY REVEALED A DORSAL¿VENTRAL GRADIENT, WITH DISCONNECTION OF ORBITOFRONTAL STREAMLINES MOST STRONGLY ASSOCIATED WITH A POSITIVE RESPONSE (P 0.0001). CONCLUSIONS: LASER ANTERIOR CAPSULOTOMY RESULTED IN IMMEDIATE, MARKED IMPROVEMENT IN OCD SYMPTOM SEVERITY. LARGER LESIONS PERMIT GREATER DISCONNECTION OF PREFRONTAL¿SUBCORTICAL PATHWAYS INVOLVED IN OCD. THE IMPORTANCE OF GREATER DISCONNECTION IS PRESUMABLY RELATED TO VARIATION IN ALIC STRUCTURE AND THE COMPLEX ROLE OF THE PFC IN OCD. REPORTABLE EVENTS: ONE PATIENT REQUIRED REOPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543273 VISUALASE SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male Required Intervention