BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE NEURO

    MDR report key: 7100410 · Received December 8, 2017

    Report

    Report Number
    9615058-2017-00006
    Event Type
    Injury
    Date Received
    December 8, 2017
    Date of Event
    September 24, 2016
    Report Date
    December 8, 2017
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    POH
    UDI-DI
    07290015461023
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETROSPECTIVE ANALYSIS OF THE TREATMENT DATA LOGS (EXABLATE TREATMENT REPORT) INDICATED THAT THE DEVICE PERFORMED AS INTENDED WITHIN SPECIFICATIONS. FURTHER ANALYSIS OF THE TREATMENT DATA LOGS SHOWS THAT THE LESION WAS LOCATED IN THE SUBTHALAMUS ZONA INCERTA REGION WHICH IS OUTSIDE OF INDICATED REGION OF TREATMENT OF ET IN THE US. FURTHERMORE, THE PATIENT'S OVERALL SKULL DENSITY RATIO ("SDR") WAS 0.35; THIS SDR IS CONTRAINDICATED FOR THE TREATMENT OF ET IN THE US USING EXABLATE NEURO (OVERALL SDR MUST BE GREATER THAN 0.45 (±0.05)). THE LAST FIVE SONICATIONS WHICH WERE PERFORMED AT A HIGHER POWER DUE TO LOWER SDR WITH THREE TARGETS INTENTIONALLY DISTRIBUTED OVER APPROXIMATELY 3MM INFERIORLY AND 1.5MM POSTERIORLY OF AN AREA. IN CONCLUSION, THIS EVENT HAS BEEN ATTRIBUTED TO THE PHYSICIAN ABLATING LARGER TARGET AREA EXTENDING VERY INFERIORLY WHICH HAS A POTENTIAL FOR CEREBRAL EDEMA AT THE ABLATION SITE IN TURN CAUSING THE REPORTED SYMPTOMS POST-TREATMENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 A (B)(6) YEAR OLD MALE PATIENT WAS TREATED WITH EXABLATE NEURO FOR ESSENTIAL TREMOR TARGETING THE SUBTHALAMUS AND SUBTHALAMUS ZONA INCERTA REGION. APPROXIMATELY 72 HOURS POST-TREATMENT, THE PATIENT REPORTEDLY EXPERIENCED MODERATE ARM AND LEG WEAKNESS AND WENT TO THE LOCAL HOSPITAL WHERE HE WAS PRESCRIBED STEROIDS. ON (B)(6) 2016 IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR 3 DAYS AND AN MRI SCAN TAKEN DURING THIS HOSPITAL STAY SHOWED EDEMA IN THE AREA OF TREATMENT. ACCORDING TO REPORTING, PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2016 COMPLAINING OF PROGRESSIVE WEAKNESS AND INTERMITTENT SWELLING OF THE RIGHT ARM AND LEG AND THAT THE LEG IS COLD AND STIFF WITH DECREASED MOBILITY. IT WAS COMMUNICATED BY THE SITE CLINICAL TEAM THAT THE STEROID DOSAGE WAS DECREASED DURING THIS VISIT. THE PATIENT REPORTEDLY RETURNED TO THE HOSPITAL ON (B)(6) 2016 COMPLAINING OF HEADACHE, DYSARTHRIA, CONFUSION, AND BLURRED VISION AND WAS ADMITTED FOR APPROXIMATELY EIGHT DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879302 EXABLATE NEURO MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC, LTD. 4000 TYPE 1 07290015461023

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R