BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6048666 · Received October 21, 2016

    Report

    Report Number
    3004962788-2016-00276
    Event Type
    Death
    Date Received
    October 21, 2016
    Date of Event
    July 10, 2016
    Report Date
    September 26, 2016
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD A SUPERDIMENSION ENB PROCEDURE ON (B)(6) 2016. THE PATIENT WAS ADMITTED ON (B)(6) 2016 IN SHOCK WITH A PULMONARY EMBOLUS. THE PATIENT WAS TRANSFERRED TO HOSPICE AND SUBSEQUENTLY DIED ON (B)(6) 2016. THE PATIENT WAS DIAGNOSED WITH ADULT FAILURE TO THRIVE DUE TO DIFFUSE LARGE B-CELL LYMPHOMA.THE SITE REPORTED THE PATIENT'S DEATH WAS NOT RELATED TO THE SUPERDIMENSION DEVICE OR THE ENB PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699649 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death