BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOMATICS AND MECTA CORPORATION

    MDR report key: 8445240 · Received March 22, 2019

    Report

    Report Number
    1420295-2019-00002
    Event Type
    Injury
    Date Received
    March 22, 2019
    Report Date
    March 21, 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

    SOMATICS BECAME AWARE OF THE CLAIMED ADVERSE EVENTS UPON RECEIPT OF A LAWSUIT FILING. THIS WAS A GENERAL CLASS ACTION LAWSUIT THAT STARTED WITH SIX INDIVIDUALS, BUT OVER THE YEARS WAS DOWN TO ONLY TWO PEOPLE. THE EXACT DATES OF ANY TREATMENTS AND ANY DOCTORS WAS NOT PROVIDED TO SOMATICS. IN GENERAL SEVERAL HOSPITALS WERE SELECTED THAT HAD THYMATRON SYSTEM IV DEVICES. THE JUDGE THREW OUT MOST OF THE COMPLAINANTS AND MOST OF THE TYPES OF INJURIES. SOMATICS RECEIVED NO SPECIFIC INFORMATION ABOUT THE TREATING PHYSICIAN, DATES OF TREATMENTS, LABORATORY RESULTS OR OTHER OBJECTIVE INFORMATION TO CORROBORATE THE COMPLAINANTS' DESCRIPTION OF THESE EVENTS. MOREOVER THE MEDICAL LITERATURE PROVIDES NO EVIDENCE OF THE CONNECTION DRAWN BY THE COMPLAINANTS BETWEEN ECT TREATMENTS AND THE SYMPTOMS REPORTED. SOMATICS MAINTAINS THAT THE THYMATRON DEVICE DID NOT CAUSE OR CONTRIBUTE TO THESE INJURIES. IN THE 12/26/2018 RULING, THE FDA ITSELF DECLARED THAT THERE IS NO DOCUMENTED PROOF THAT ECT CAUSES ANY BRAIN DAMAGE OR THESE TYPES OF ALLEGED INJURIES. THESE EVENTS WERE REPORTED TO THE COMPANY THROUGH LEGAL CHANNELS WHICH LIMITED THE COMPANY'S ABILITY TO CONDUCT A FULL INVESTIGATION, ACCORDINGLY, OUT OF ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803, SOMATICS IS REPORTING THESE EVENTS BASED ON THE ALLEGATIONS THAT WERE MADE RATHER THAN BECAUSE IT REACHED ANY CONCLUSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THESE INJURIES.

    Description of Event or Problem · 1

    (B)(6) AND SEVERAL COMPLAINANTS CLAIMED MULTIPLE ADVERSE AFFECTS INCLUDING PERMANENT BRAIN INJURY, SEVERE COGNITIVE AND MEMORY IMPAIRMENT AND ORGANIC BRAIN SYNDROME. THIS WAS PART OF THE LITIGATION FOR A CLASS ACTION SUIT AGAINST BOTH SOMATICS AND MECTA CORPORATION, OR IN GENERAL AGAINST ECT PRACTICE. MOST MEMBERS OF THE LITIGATION WERE ELIMINATED BECAUSE THEY COULD NOT PROVIDE DOCUMENTATION OF THEIR TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237209 SOMATICS AND MECTA CORPORATION THYMATRON SYSTEM IV AND MECTA SPRECTRUM 5000 GXC SOMATICS, LLC SYSTEM IV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other