BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 11905759 · Received May 30, 2021

    Report

    Report Number
    9615058-2021-00012
    Event Type
    Injury
    Date Received
    May 30, 2021
    Date of Event
    April 20, 2021
    Report Date
    July 18, 2021
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE TREATING PHYSICIAN, THE PATIENT IS IN NORMAL HEALING PROCESS WITH ANTICIPATED (BALANCE ISSUE) SIDE EFFECT. THEREFORE NO INVESTIGATION IS NEEDED.

    Description of Event or Problem · 0

    FOLLOWING BRAIN TREATMENT FOR TREMOR, PATIENT MENTIONED IN A CALL WITH THE CLINICAL EDUCATOR THAT SHE "FALLING A LOT" (IMBALANCE). THIS FOLLOW UP REPORT IS SUBMITTED TO REFLECT TREATING PHYSICIAN RESPONSE (SEE SECTION H10).

    Additional Manufacturer Narrative · 1

    THIS CASE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    FOLLOWING BRAIN TREATMENT FOR TREMOR, PATIENT MENTIONED IN A CALL WITH THE CLINICAL EDUCATOR THAT SHE "FALLING A LOT" (IMBALANCE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802437 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability