BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 11654544 · Received April 13, 2021

    Report

    Report Number
    9615058-2021-00009
    Event Type
    Injury
    Date Received
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS POSTED ON THE COMPANY'S WEBSITE. THERE WERE NOT ENOUGH DETAILS TO LOCATE THE SPECIFIC TREATMENT. NOT ENOUGH DETAILS TO INVESTIGATE. THE COMPLAINANT RECEIVED POST BACK THAT HE SHOULD CONTACT HIS TREATING PHYSICIAN OR HIS TREATMENT FACILITY.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED AS MESSAGE FROM COMPANY'S WEBSITE. IN THE MESSAGE THE COMPLAINANT MENTIONED THAT HER HUSBAND STILL EXPERIENCING "LEFT LEG THAT DOESN'T DRAG", "NUMB FACE", "DROOLING" AND "NUMB LEFT HAND" 18 MONTHS AFTER ESSENTIAL TREMOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551735 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability