BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 11884319 · Received May 26, 2021

    Report

    Report Number
    9615058-2021-00011
    Event Type
    Injury
    Date Received
    May 26, 2021
    Date of Event
    April 19, 2021
    Report Date
    July 18, 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 · 0

    THE RETROSPECTIVE ANALYSIS HAS NOT INDICATED ANY TECHNICAL FAILURES OPERATION OF THE SYSTEM. TREATMENT PARAMETERS WERE IN LINE WITH THE 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

    IN FOLLOW UP CALL FROM THE CLINICAL EDUCATOR ONE DAY AFTER ESSENTIAL TREMOR TREATMENT THE PATIENT STATED THAT HE HAD SOME DIZZINESS. EIGHT DAYS AFTER THE CONVERSATION, IN AN ADDTIONAL FOLLOW UP CALL FROM THE CLINICAL EDUCATOR, THE PATIENT STATED THAT HE ADMITTED TO THE HOSPITAL FOLLOWING A MILD STROKE. THIS FOLLOW UP REPORT IS SUBMITTED TO REFLECT THE COMPLETION OF INTERNAL INVESTIGATION (SEE SECTION H10) AND TO UPDATE WITH THE FOLLOWING: THE IMAGING FINDINGS WERE MISDIAGNOSED BY ER TEAM AS STROKE, NOT KNOWING THAT THESE WERE NORMAL POST ABLATION FINDINGS. FURTHERMORE THE PATIENT DID EXPERIENCE DIFFICULTY WITH STRENGTH, COORDINATION AND DEXTERITY. A RECENT VISIT TO THE HOSPITAL (ER) DID NOT REVEAL ANY ACUTE ABNORMALITIES OR STROKE EVIDANCE.

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THERE IS NOT ENOUGH INFORMATION TO DETERMINE WHAT IS THE RESULT OF THE REPORTED "MILD STROKE" OR IF IT IS RELATED TO THE TREATMENT. THIS CASE IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    IN FOLLOW UP CALL FROM THE CLINICAL EDUCATOR ONE DAY AFTER ESSENTIAL TREMOR TREATMENT THE PATIENT STATED THAT HE HAD SOME DIZZINESS. EIGHT DAYS AFTER THE CONVERSATION, IN AN ADDITIONAL FOLLOW UP CALL FROM THE CLINICAL EDUCATOR, THE PATIENT STATED THAT HE ADMITTED TO THE HOSPITAL FOLLOWING A MILD STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785008 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S