BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE NEURO

    MDR report key: 7097194 · Received December 7, 2017

    Report

    Report Number
    9615058-2017-00005
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    June 13, 2017
    Report Date
    December 7, 2017
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    POH
    UDI-DI
    07290015461023
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETROSPECTIVE ANALYSIS OF THE TREATMENT DATA SHOWED THAT THE DEVICE PERFORMED AS INTENDED. DUE TO THE PATIENT COMPLAINING OF THE HEADACHE DURING THE TREATMENT, THE PHYSICIAN DECIDED TO EXTEND THE SONICATION TIME TO UP TO 28SEC, WHILE REDUCING THE POWER SO THAT THE EXACT AMOUNT ENERGY REQUIRED IS UNCHANGED. THIS APPROACH LIKELY CAUSED A MEDIAL-LATERAL SMEARING AND ELONGATED SUPERIOR-INFERIOR HEAT SPREAD. THE EVENT OF "ELONGATED" SONICATION THERMAL SPOTS AND THE REQUIRED MITIGATING STEPS TO MANAGE SUCH EVENTS ARE ALREADY PART OF PHYSICIAN TRAINING MATERIAL: USING THE EXABLATE SW FEATURE OF THE LOW POWER ACT TEMPORAL MASK TO MANAGE THE EFFECT ON SPOT SHAPE; MARKING OFF THE HYPEROSTOSIS WITH NPRS AND TILTING THE TRADUCER (PITCH) TO AVOID THIS FOCAL AREA WOULD HAVE POTENTIALLY RESULTED IN NON-SMEARED TIGHTER FOCAL HEAT; IT IS HIGHLY RECOMMENDED TO USE SHORTER SONICATION DURATIONS TO MITIGATE A MEDIAL-LATERAL SMEARING AND ELONGATED SUPERIOR-INFERIOR HEAT SPREAD. INSIGHTEC HAS DISCUSSED THIS ANALYSIS AND THE MITIGATING STEPS (AS DESCRIBED ABOVE) WITH THE TREATING PHYSICIAN. FURTHER PHYSICIAN FEEDBACK ON PATIENT STATUS INDICATED PATIENT SHOWED GOOD SIGNS OF IMPROVEMENT AND IS SATISFIED WITH TREATMENT OUTCOMES.INSIGHTEC INTERNAL REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) FEMALE PATIENT HAD AN EXABLATE MRGFUS PROCEDURE TO THE LEFT VIM TARGET FOR THE TREATMENT OF ESSENTIAL TREMOR (ET). IT WAS REPORTED THAT THE PATIENT REPEATEDLY STOPPED SONICATIONS DUE TO PAIN AND AT THE END OF THE TREATMENT EXPERIENCED SOME NAUSEA. COMPLETE TREMOR RELIEF WAS REPORTED FOLLOWING THE TREATMENT. AT THE 11-DAY POST-TREATMENT FOLLOW UP, IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE FACIAL NUMBNESS AND TEMPERATURE SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876039 EXABLATE NEURO MR-GUIDED FOCUSED ULTRASOUND SYSTEM, POH INSIGHTEC, LTD. 4000 TYPE 1 07290015461023

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other