BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM ECT DEVICE

    MDR report key: 10678301 · Received October 14, 2020

    Report

    Report Number
    3020533-2020-00004
    Event Type
    Injury
    Date Received
    October 14, 2020
    Report Date
    October 13, 2020
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS 2ND LAWSUIT (BOTH NEARLY IDENTICAL) BROUGHT BY THESE LAW FIRMS.

    Description of Event or Problem · 1

    LAW SUIT CLAIMING NEUROCOGNITIVE INJURIES, MEMORY LOSS, IMPAIRED VISUAL, AND VERBAL MEMORY, SIGNIFICANT DECLINE IN ABILITY TO LEARN AND RECALL INFORMATION, DISRUPTION AND DECLINE IN ABILITY TO ENCODE NEW INFORMATION, LOSS OF EXECUTIVE FUNCTION AND ADDITIONAL PHYSICAL AND PSYCHOLOGICAL HARMS. PATIENT 1 ALLEGEDLY HAD 24 ECT TREATMENTS IN (B)(6) 2018. PATIENT 2 ALLEGEDLY HAD 41 ECT TREATMENTS IN (B)(6) 2013-(B)(6) 2015. PATIENT 3 ALLEGEDLY HAD 14 ECT TREATMENTS IN (B)(6) 2018. PATIENT 4 ALLEGEDLY HAD 47 ECT TREATMENTS IN (B)(6) 2007- (B)(6) 2008. PATIENT 5 ALLEGEDLY HAD 51 ECT TREATMENTS IN (B)(6) 2006- (B)(6) 2007. AT THIS TIME, NO OTHER INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142449 SPECTRUM ECT DEVICE GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S