BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 9870842 · Received March 24, 2020

    Report

    Report Number
    9615058-2020-00007
    Event Type
    Injury
    Date Received
    March 24, 2020
    Date of Event
    February 12, 2020
    Report Date
    March 24, 2020
    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

    THE (B)(6) POST COULD NOT BE CONFIRMED WITH THE TREATING PHYSICIAN. NOT ENOUGH DETAILS TO LOCATE THE SITE OR THE SPECIFIC TREATMENT. NOT ENOUGH DETAILS TO INVESTIGATE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS POSTED ON INSIGHTEC (B)(6) PAGE. THE PATIENT STATED THAT SHE HAD BRAIN TREATMENT FOR ESSENTIAL TREMOR 2 WEEKS AGO (APPARENTLY ON (B)(6) 2020) AND SINCE THEN SHE HAS "SIGNIFICANT RIGHT SIDE WEAKNESS". BASED ON THE AVAILABLE INFORMATION, THE COMPANY HAS NOT ENOUGH DETAILS TO LOCATE THE SITE OR THE TREATING PHYSICIAN. THE COMPLAINANT RECEIVED A POST BACK THAT SHE SHOULD REACH HER TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336107 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability