BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECT DEVICE

    MDR report key: 14628080 · Received June 7, 2022

    Report

    Report Number
    3020533-2022-00003
    Event Type
    Death
    Date Received
    June 7, 2022
    Date of Event
    December 31, 2015
    Report Date
    June 7, 2022
    Manufacturer
    MECTA CORPORATION
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS FROM A MEDWATCH REPORT FILED BY A CORONER'S OFFICE. WE ATTEMPTED TO CALL THREE TIMES AT THE NUMBER GIVEN ON THE REPORT WITH DETAILED VOICEMAIL MESSAGES STATING THAT (B)(4), WAS ON THE REPORT AND THAT WE WERE INVESTIGATING AND HAD SOME QUESTIONS. ALSO, WE WROTE 3 EMAILS WITH THE SAME DETAILED INFORMATION TO THEIR GENERAL EMAIL ADDRESS ON THEIR WEBSITE. HOWEVER, THERE HAS BEEN NO REPLY TO ANY OF OUR INQUIRIES EITHER PHONE OR EMAIL. HENCE, IT WAS NOT POSSIBLE TO FOLLOW UP IN ANY WAY.

    Description of Event or Problem · 0

    PATIENT HAD THREE SESSIONS OF ECT IN 2015 FOR A PSYCHIATRIC DIAGNOSIS OF DEPRESSIVE DISORDER OF A SEVERE DEGREE WITH A SUSPECTED UNDERLYING COGNITIVE IMPAIRMENT AND LEARNING DISABILITY. PATIENT DEVELOPED FOCAL SEIZURES AND STATUS ECLIPTICS, WHICH REQUIRED HER TRANSFER TO THE HIGH DEPENDENCY UNIT OF THE HOSPITAL AND THEN WAS DISCHARGED BACK TO THE WARD AT THE HOSPITAL. PATIENT APPEARED TO DEVELOP ASPIRATION PNEUMONIA AND ALTHOUGH SHE WAS TREATED WITH ANTIBIOTICS, HER DECLINE CONTINUED AND SHE DIED IN 2015. POST-MORTEM EXAMINATION GAVE THE CAUSE OF DEATH AS ANOXIC-ISCHEMIC BRAIN DAMAGE DUE TO STATUS EPILEPTICUS DUE TO ELECTRO-CONVULSIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2196366 ECT DEVICE ECT DEVICE GXC MECTA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death