BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATICS, LLC

    MDR report key: 8545182 · Received April 24, 2019

    Report

    Report Number
    1420295-2019-00005
    Event Type
    Injury
    Date Received
    April 24, 2019
    Report Date
    April 24, 2019
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    PMA / PMN Number
    945120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY HAS RECEIVED A LEGAL COMPLAINT AND IS UNABLE TO INVESTIGATE DUE TO LEGAL CONSTRAINTS WITHIN THE ALLOTTED REPORTING PERIOD. AS A RESULT, THE COMPANY IS REPORTING OUT OF ABUNDANCE OF CAUTION BASED SOLELY ON THE ALLEGATIONS CONTAINED IN THE LAWSUIT. IF AND WHEN THE COMPANY IS PERMITTED TO CONDUCT A PROPER INVESTIGATION, IT WILL BE ABLE TO DETERMINE IF ITS DEVICE CAUSED THE ALLEGED INJURIES. THE INFORMATION CURRENTLY AVAILABLE SUGGESTS THAT IT IS UNLIKELY. THE DECEMBER 2018 FDA PUBLICATION STATED THERE IS NO PROOF THAT ECT CAUSES THIS INJURY. SOMATICS WILL SUPPLEMENT THIS REPORT ACCORDINGLY.

    Description of Event or Problem · 1

    MS. (B)(6) FILED A LAWSUIT CLAIMING MULTIPLE "SERIOUS" INJURIES. SOME OF THESE ALLEGED INJURIES ARE: BRAIN DAMAGE; NEUROCOGNITIVE INJURIES; PERMANENT MEMORY LOSS; AND SEVERAL OTHER ALLEGED INJURIES SINCE THIS IS JUST THE BEGINNING OF THE LAWSUIT SOMATICS WILL NOT BE ABLE TO CONFIRM ANY OF THESE ALLEGATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339368 SOMATICS, LLC THYMATRON SYSTEM IV GXC SOMATICS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other