BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATICS, LLC

    MDR report key: 10466651 · Received August 28, 2020

    Report

    Report Number
    1420295-2020-00010
    Event Type
    Injury
    Date Received
    August 28, 2020
    Report Date
    August 28, 2020
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    PMA / PMN Number
    945120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ORIGINAL REPORT FROM SOMATICS, 140295-2020-00010 WAS SENT IN AUGUST 2020. THOROUGH INVESTIGATION OF THE COMPLAINANT (B)(6) MEDICAL RECORDS WAS UNDERTAKEN BY AN IMPARTIAL EXAMINER WHO IS A BOARD-CERTIFIED PSYCHIATRIST AND NEUROLOGIST. THIS EXAMINER FOUND NO EVIDENCE IN THE MEDICAL RECORDS TO SUPPORT COMPLAINANT'S CLAIMS OF MEMORY IMPAIRMENT, COGNITIVE IMPAIRMENT OR 'BRAIN DAMAGE" RESULTING FROM ECT TREATMENT WITH THE THYMATRON ECT INSTRUMENT. THIS CONCLUDES SOMATICS' MEDWATCH REPORT ABOUT COMPLAINTS STATED BY (B)(6).

    Description of Event or Problem · 0

    MR. (B)(6) CLAIMS MULTIPLE INJURIES INCLUDING BRAIN DAMAGE, COGNITIVE IMPAIRMENTS AND OTHER ISSUES.

    Description of Event or Problem · 1

    MR. THELEN CLAIMS MULTIPLE INJURIES INCLUDING BRAIN DAMAGE, COGNITIVE IMPAIRMENTS AND OTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933368 SOMATICS, LLC ELECTROCONVULSIVE THERAPY INSTRUMENT GXC SOMATICS, LLC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other