BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 11947250 · Received June 7, 2021

    Report

    Report Number
    9615058-2021-00014
    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. THE COMPLAINANT RECEIVED AN ANSWER THAT HE SHOULD CONTACT THE TREATING PHYSICIAN. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Description of Event or Problem · 1

    IN POST THAT WAS RECEIVED FROM THE COMPANY'S WEBSITE THE PATIENT MENTIONED THAT HE "NO LONGER SHAKE HIS LEFT HAND" BUT HAD "NUMEROUS SIDE EFFECTS". NO SPECIFIC SIDE EFFECT WAS DESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841640 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability