BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 12030237 · Received June 20, 2021

    Report

    Report Number
    9615058-2021-00015
    Event Type
    Injury
    Date Received
    June 20, 2021
    Report Date
    June 20, 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. THE COMPLAINANT RECEIVED AN ANSWER THAT HE SHOULD CONTACT THE TREATING PHYSICIAN OR SUBMIT A REPORT TO INSIGHTEC'S WEBSITE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED VIA THE COMPANY (B)(6) PAGE. IN THE POST THE PATIENT MENTIONED THAT AFTER TREATMENT THE TREMOR WAS CURED BUT HE "CAN'T WALK AND HAVE FALLEN DOWN SEVERAL TIMES" (GAIT DISTURBANCES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927125 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability