BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 11947191 · Received June 7, 2021

    Report

    Report Number
    9615058-2021-00013
    Event Type
    Injury
    Date Received
    June 7, 2021
    Report Date
    June 7, 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 · 1

    BASED ON THE AVAILABLE INFORMATION, THE COMPANY DOES NOT HAVE ENOUGH DETAILS TO INVESTIGATE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED FROM THE COMPANY (B)(6) PAGE. IN THE POST THE PATIENT MENTIONED FEW SIDE EFFECTS THAT PERSIST 4 YEARS AFTER ESSENTIAL TREMOR TREATMENT : IMBALANCE, GAIT DISTURBANCE, NUMBNESS AND TASTE BUDS FUNCTIONING (DYSGEUSIA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841622 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability