BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXABLATE 4000

    MDR report key: 9999868 · Received April 27, 2020

    Report

    Report Number
    9615058-2020-00009
    Event Type
    Injury
    Date Received
    April 27, 2020
    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

    THERE WERE NOT ENOUGH DETAILS TO LOCATE THE SITE, THE SPECIFIC TREATMENT OR THE TREATING PHYSICIAN. NOT ENOUGH DETAILS TO INVESTIGATE.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS POSTED ON INSIGHTEC FACEBOOK PAGE. ACCORDING TO THE POST, THE PATIENT WENT THROUGH A BRAIN TREATMENT, TO ADDRESS ESSENTIAL TREMOR. THE PATIENT REPORTED A RESOLUTION OF THE RIGHT HAND TREMOR. THE PATIENT LISTED THE FOLLOWING EFFECTS: " CAN NO LONGER PLAY THE PIANO OR WRITE LEGIBLY OR WALK STEADILY". BASED ON THE AVAILABLE INFORMATION, THE COMPANY DOES NOT HAVE ENOUGH DETAILS TO LOCATE THE SITE OR THE TREATING PHYSICIAN. THE COMPLAINANT RECEIVED A POST BACK THAT HE SHOULD REACH HIS TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE. ANOTHER POST WAS RECEIVED FROM THE SAME PATEINT ADDED MORE SYMPTOMS "THE ANTERIOR THIRD OF THE TONGUE IS PARTIALLY NUMB AND TROUBLE SPEAKING CLEARLY". THE COMPANY STILL DOES NOT HAVE ENOUGH DETAILS TO LOCATE THE SITE OR THE TREATING PHYSICIAN. THE COMPLAINANT RECEIVED AGAIN POST BACK THAT HE SHOULD REACH HIS TREATING PHYSICIAN OR CONTACT INSIGHTEC FORMAL WEBSITE. NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS CASE SO FAR.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS POSTED ON THE COMPANY (B)(6) PAGE. THERE WERE NOT ENOUGH DETAILS TO LOCATE THE SITE, THE SPECIFIC TREATMENT OR THE TREATING PHYSICIAN. NOT ENOUGH DETAILS TO INVESTIGATE.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS POSTED ON INSIGHTEC (B)(6) PAGE. ACCORDING TO THE POST, THE PATIENT WENT THROUGH A BRAIN TREATMENT, TO ADDRESS ESSENTIAL TREMOR. THE PATIENT REPORTED A RESOLUTION OF THE RIGHT HAND TREMOR. THE PATIENT LISTED THE FOLLOWING EFFECTS: " CAN NO LONGER PLAY THE PIANO OR WRITE LEGIBLY OR WALK STEADILY". BASED ON THE AVAILABLE INFORMATION, THE COMPANY DOES NOT HAVE ENOUGH DETAILS TO LOCATE THE SITE OR THE TREATING PHYSICIAN. THE COMPLAINANT RECEIVED A POST BACK THAT SHE SHOULD REACH HIS 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
    465203 EXABLATE 4000 MR GUIDED FOCUSED ULTRASOUND SYSTEM POH INSIGHTEC LTD 4000

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability