BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 9975726 · Received April 19, 2020

    Report

    Report Number
    9615058-2020-00008
    Event Type
    Injury
    Date Received
    April 19, 2020
    Date of Event
    October 10, 2019
    Report Date
    June 14, 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 · 0

    THIS REVIEW OF THIS TREATMENT HAS NOT INDICATED ANY TECHNICAL FAILURES OF THE SYSTEM.TREATMENT PARAMETERS WERE IN LINE WITH TYPICAL RANGE. THE SYSTEM PERFORMANCE WAS FOUND TO BE ACCORDING TO SPEC AND AS EXPECTED.NO NEW RISK WAS RECOGNIZED.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS RECEIVED FROM INSIGHTEC FACEBOOK PAGE. IN THE POST THE PATEINT COMPLAINED THAT AFTER TREATMENT "THE TREMOR AND OTHER SIDE EFFECT GOT WORSE". THE COMPANY SUCCEEDED TO LOCATE THE SITE (CLEVELAND CLINIC, FLORIDA) AND THE TREATING PHYSICIAN (DR. NAGEL) , WHO INDICATED THAT THERE WERE NO UNEXPECTED SIDE EFFECTS AFTER TREATMENT. AROUND A WEEK AFTER THE INITIAL COMMUNICATION WITH THE SITE, THE LOCAL NEUROLOGIST (DR. JONES) PERFORMED A TELEPHONE FOLLOW UP WITH THE PATEINT AND INDICATED TO THE COMPANY THAT THE PATEINT HAD SIGNIFICANT WORSENING OF HIS BALANCE. THE COMPLAINANT RECEIVED A POST BACK THAT HE SHOULD REACH HIS TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE. THIS FOLLOW UP REPORT IS SUBMITTED TO REFLECT THE COMPLETION OF INTERNAL INVESTIGATION (SEE SECTION H10).

    Additional Manufacturer Narrative · 1

    THIS CASE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS RECEIVED FROM (B)(6) PAGE. IN THE POST THE PATIENT COMPLAINED THAT AFTER TREATMENT "THE TREMOR AND OTHER SIDE EFFECT GOT WORSE". THE COMPANY SUCCEEDED TO LOCATE THE SITE (B)(6)) AND THE TREATING PHYSICIAN (DR. (B)(6)) , WHO INDICATED THAT THERE WERE NO UNEXPECTED SIDE EFFECTS AFTER TREATMENT. AROUND A WEEK AFTER THE INITIAL COMMUNICATION WITH THE SITE, THE LOCAL NEUROLOGIST (DR. (B)(6)) PERFORMED A TELEPHONE FOLLOW UP WITH THE PATIENT AND INDICATED TO THE COMPANY THAT THE PATIENT HAD SIGNIFICANT WORSENING OF HIS BALANCE. THE COMPLAINANT RECEIVED A POST BACK THAT HE SHOULD REACH HIS TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439447 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability