BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 12710842 · Received October 28, 2021

    Report

    Report Number
    9615058-2021-00030
    Event Type
    Injury
    Date Received
    October 28, 2021
    Date of Event
    September 28, 2021
    Report Date
    November 10, 2021
    Manufacturer
    INSIGHTEC LTD
    Product Code
    POH
    PMA / PMN Number
    P150038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT INCLUDED KNOWN TRANSIENT SIDE EFFECTS. NO MALFUNCTION WAS DESCRIBED. NO NEW RISK HAS BEEN RECOGNIZED.

    Description of Event or Problem · 0

    ARM WEAKNESS, SLURRED SPEECH, AND BALANCE ISSUES (IMBALANCE) 1 DAY POST ESSENTIAL TREMOR TREATMENT. ACCORDING TO THE NEW INFORMATION RECEIVED FROM THE TREATING PHYSICIAN: THE REPORTED SIDE EFFECTS ARE TRANSIENT AND WILL BE RESOLVED, THE TREMOR HAS REDUCED SIGNIFICANTLY.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ARM WEAKNESS, SLURRED SPEECH, AND BALANCE ISSUES (IMBALANCE) 1 DAY POST ESSENTIAL TREMOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1612339 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability