BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABALTE 4000

    MDR report key: 8543551 · Received April 24, 2019

    Report

    Report Number
    9615058-2018-00013
    Event Type
    Injury
    Date Received
    April 24, 2019
    Date of Event
    May 11, 2018
    Report Date
    June 4, 2019
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P1500038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    ON NOVEMBER 27, 2018, INSIGHTEC WAS NOTIFIED THAT A PATIENT WHO WAS TREATED FOR ESSENTIAL TREMOR ON (B)(6) 2018 AT (B)(6), REPORTED MILD RIGHT SIDE DROOLING AND INCOORDINATION. INSIGHTEC LATER LEARNED THAT UPON EXAMINATION, THE ONLY ISSUE THE PATIENT WAS EXPERIENCING WAS THE TASTE DISTURBANCE. THIS REPORT IS SUBMITTED TO CORRECT THE ORIGINAL REPORT SUBMITTED TO FDA.

    Additional Manufacturer Narrative · 1

    THE SYSTEM TECHNICAL PERFORMANCE DURING TREATMENT WAS THOROUGHLY REVIEWED;NO TECHNICAL ISSUES WERE FOUND. NO SYSTEM MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    ON (B)(6) 2018, INSIGHTEC WAS NOTIFIED, THAT PATIENT WHO WAS TREATED ON (B)(6) 2018, REPORTED OF ON SOME TASTE ISSUES, ATAXIA AND RLE WEAKNESS. BY THE OCTOBER 1ST FOLLOW UP, THE PATIENT REPORTED VERY MILD RIGHT SIDED DROOLING AND INCOORDINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338292 EXABALTE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Disability