BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 6938708 · Received October 10, 2017

    Report

    Report Number
    9615058-2017-00004
    Event Type
    Injury
    Date Received
    October 10, 2017
    Date of Event
    September 12, 2017
    Report Date
    October 10, 2017
    Manufacturer
    INSIGHTEC, LTD.
    Product Code
    POH
    UDI-DI
    07290015461023
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2017, PATIENT IS REPORTED TO HAVE SENSORY FUNCTIONS FULLY RECOVERED AND ATTENDING PLANNED NEUROLOGICAL REHAB AS A PART OF THE TREATMENT. NO PERMANENT IMPAIRMENT RELATED TO THE EXABLATE TREATMENT HAS BEEN REPORTED BY THE TREATING PHYSICIAN.

    Additional Manufacturer Narrative · 1

    THE RETROSPECTIVE ANALYSIS OF THE TREATMENT HAS NOT INDICATED ANY SYSTEM TECHNICAL FAILURES OR USER ERROR. THE EXABLATE NEURO FUNCTIONED AS INTENDED. SWELLING OF SURROUNDING TISSUE WITH ASSOCIATED NEUROLOGICAL DEFICITS OR SYMPTOMS HAS BEEN REPORTED AFTER TREATMENT WITH EXABLATE NEURO; SUCH EVENTS HAVE BEEN TRANSIENT IN NATURE. THE RISK IS INHERENT TO THE PROCEDURE. APPROXIMATELY 2 WEEKS AFTER THE TREATMENT, THE TREATING PHYSICIAN REPORTED THAT THE PATIENT IS DOING BETTER AND WAS RELEASED HOME. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR THE ESSENTIAL TREMOR WITH EXABLATE NEURO AT (B)(6) HOSPITAL ((B)(6)). ONE DAY AFTER THE TREATMENT, THE PHYSICIAN REPORTED THAT THE PATIENT EXPERIENCED WEAKNESS OF RIGHT UPPER EXTREMITY, THE RIGHT SIDE OF THE PATIENT'S MOUTH APPEARED TO BE BENT DOWNWARD AND THE PATIENT WAS SLURRING HIS SPEECH. THE MR SCANS TAKEN THE MORNING AFTER THE TREATMENT SHOWED EDEMA BEYOND THE TREATMENT SPOT. THE PATIENT REMAINED IN THE HOSPITAL. APPROXIMATELY 2 WEEKS AFTER THE TREATMENT THE TREATING PHYSICIAN REPORTED THAT THE PATIENT IS DOING BETTER AND WAS RELEASED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718287 EXABLATE 4000 MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC, LTD. EXABLATE 4000 07290015461023

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| O