BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 10539077 · Received September 16, 2020

    Report

    Report Number
    9615058-2020-00020
    Event Type
    Injury
    Date Received
    September 16, 2020
    Date of Event
    November 8, 2019
    Report Date
    September 16, 2020
    Manufacturer
    INSIGHTEC
    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

    THE SITE IS NOT ABLE TO PROVIDE INFORMATION DUE TO HIPPA RESTRICTIONS.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED TO INSIGHTEC THAT HIS WIFE EXPERIANCE BALANCE ISSUE AFTER ESSENTIAL TREMOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007895 EXABLATE 4000 MR-GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability