BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 13174065 · Received January 6, 2022

    Report

    Report Number
    9615058-2022-00001
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 12, 2020
    Report Date
    November 17, 2022
    Manufacturer
    INSIGHTEC LTD.
    Product Code
    POH
    UDI-DI
    07290015461021
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE IS STILL UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDED KNOWN SIDE EFFECT. NO NEW RISKS WERE IDENTIFIED. NO DEVICE MALFUNCTION WAS DETECTED. TREATMENT PARAMETERS WERE IN LINE WITH THE TYPICAL RANGE.

    Description of Event or Problem · 0

    INSIGHTEC INITIALLY RECEIVED A REPORT AS TO THIS EVENT DIRECTLY FROM THE PATIENT VIA CONTACT WITH AN INSIGHTEC EDUCATOR IN (B)(6) 2021. THE PATIENT INDICATED AT THAT TIME THAT SHE EXPERIENCED A STROKE FOUR DAYS AFTER THE TREATMENT AND SOUGHT TREATMENT FOR SUCH BY PHYSICIANS AT A LOCAL HOSPITAL. THE PATIENT FURTHER INDICATED THAT HER PHYSICIANS ADVISED THAT THE STROKE WAS MOST LIKELY UNRELATED TO TREATMENT. BASED ON THE LIMITED INFORMATION AVAILABLE AT THAT TIME AS CONVEYED BY THE PATIENT, THE COMPANY'S DETERMINATION WAS THAT THE EVENT IS UNRELATED TO THE TREATMENT OR THE DEVICE. THE PATIENT FOLLOWED UP APPROXIMATELY 11 MONTHS LATER VIA A COMPLAINT REPORTED ON THE INSIGHTEC WEBSITE, REITERATING THAT SHE HAD A STROKE FOUR DAYS AFTER TREATMENT AND ALSO INDICATING THAT SHE WAS CONTINUING TO EXPERIENCE "ERRATIC AND UNCONTROLLABLE MOVEMENTS" AND TREMORS IN HER ARMS AND HANDS.

    Description of Event or Problem · 0

    INSIGHTEC INITIALLY RECEIVED A REPORT AS TO THIS EVENT DIRECTLY FROM THE PATIENT VIA CONTACT WITH AN INSIGHTEC EDUCATOR IN JANUARY 2021. THE PATIENT INDICATED AT THAT TIME THAT SHE EXPERIENCED A STROKE FOUR DAYS AFTER THE TREATMENT AND SOUGHT TREATMENT FOR SUCH BY PHYSICIANS AT A LOCAL HOSPITAL. THE PATIENT FURTHER INDICATED THAT HER PHYSICIANS ADVISED THAT THE STROKE WAS MOST LIKELY UNRELATED TO TREATMENT. BASED ON THE LIMITED INFORMATION AVAILABLE AT THAT TIME AS CONVEYED BY THE PATIENT, THE COMPANY'S DETERMINATION WAS THAT THE EVENT IS UNRELATED TO THE TREATMENT OR THE DEVICE. THE PATIENT FOLLOWED UP APPROXIMATELY 11 MONTHS LATER VIA A COMPLAINT REPORTED ON THE INSIGHTEC WEBSITE, REITERATING THAT SHE HAD A STROKE FOUR DAYS AFTER TREATMENT AND ALSO INDICATING THAT SHE WAS CONTINUING TO EXPERIENCE "ERRATIC AND UNCONTROLLABLE MOVEMENTS" AND TREMORS IN HER ARMS AND HANDS, WORSE IN THE LEFT, UNTREATED ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791143 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD. 4000 07290015461021

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Disability