BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECT DEVICE

    MDR report key: 11845022 · Received May 18, 2021

    Report

    Report Number
    3020533-2021-00004
    Event Type
    Injury
    Date Received
    May 18, 2021
    Date of Event
    April 15, 2018
    Report Date
    May 18, 2021
    Product Code
    GXC
    PMA / PMN Number
    K965070
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FROM A MEDWATCH REPORT FILED BY A PATIENT WHO GAVE NO CONTACT INFORMATION. HENCE, IT WAS NOT POSSIBLE TO FOLLOW UP IN ANY WAY.

    Description of Event or Problem · 1

    PATIENT HAD 22 ECT SESSIONS. CLAIMS COGNITIVE, PTSD, LONG TERM MEMORY ISSUES, DEPRESSION, VISUAL AND HEARING DISTURBANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740483 ECT DEVICE GXC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S