BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THYMATRON

    MDR report key: 10017455 · Received May 1, 2020

    Report

    Report Number
    1420295-2020-00005
    Event Type
    Injury
    Date Received
    May 1, 2020
    Report Date
    April 6, 2020
    Manufacturer
    SOMATICS, LLC
    Product Code
    GXC
    PMA / PMN Number
    945120
    Removal / Correction Number
    MW 5094073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SOMATICS BECAME AWARE OF THIS EVENT THROUGH THE ANONYMOUSLY SUBMITTED MEDWATCH PATIENT REPORT PROVIDED TO FDA FOR EVENT DATE OF (B)(6) 2018 AND SUBMITTED TO THE FDA ON (B)(6) 2020. THIS REPORT DOES NOT PROVIDE ANY CONTACT INFORMATION FOR THE COMPLAINANT, TREATING PHYSICIAN OR FACILITY, NOR ANY ADDITIONAL INFORMATION ABOUT THE PATIENT, THE TREATMENT OR CIRCUMSTANCES SURROUNDING THE REPORTED EVENT. THE REPORT ALSO DOES NOT PROVIDE ANY LABORATORY RESULTS OR OTHER OBJECTIVE INFORMATION TO CORROBORATE THE COMPLAINANT'S DESCRIPTION OF THE ADVERSE EFFECTS SUFFERED IN RELATION TO ELECTROCONVULSIVE THERAPY. IN ADDITION, THE REPORT INDICATES A LACK OF KNOWLEDGE AS TO WHICH DEVICE MODEL THE PATIENT WAS TREATED WITH., BECAUSE NO DOCTOR, HOSPITAL OR OTHER INFORMATION WAS PROVIDED. BECAUSE OF THE LACK OF IDENTIFYING INFORMATION AND SPECIFICS IN THE REPORT, SOMATICS IS UNABLE TO FOLLOW UP WITH ANY INVOLVED PARTIES TO LEARN MORE ABOUT WHAT MAY HAVE HAPPENED AND TO CONFIRM WHETHER THE COMPLAINANT WAS EVEN TREATED WITH ITS THYMATRON DEVICE. MOREOVER, THE MEDICAL LITERATURE PROVIDES NO EVIDENCE OF THE CONNECTION DRAWN BY THE COMPLAINANT BETWEEN ECT TREATMENT AND THE SYMPTOMS REPORTED. ALTHOUGH THE COMPANY HAS DETERMINED THAT THE SUBJECT EVENT IN THIS MDR IS LIKELY NOT REPORTABLE, BECAUSE SOMATICS IS UNABLE FOLLOW-UP WITH THE COMPLAINANT OR OTHERWISE AFFIRMATIVELY DETERMINE WHETHER THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT, AND/OR WHETHER THE ECT DEVICE IN QUESTION WAS EVEN THE ONE MANUFACTURED BY SOMATICS, THE COMPANY IS SUBMITTING THIS REPORT TO FDA IN AN ABUNDANCE OF CAUTION AND TO ENSURE FULL COMPLIANCE WITH 21 CFR PART 803.

    Description of Event or Problem · 1

    SEVERAL MEMORY, LANGUAGE AND OTHER ISSUES ALLEGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482549 THYMATRON ECT INSTRUMENT GXC SOMATICS, LLC EDIV

    Patients

    Seq Age Sex Outcome Treatment
    1 Other