BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH BRONCHUS SYSTEM

    MDR report key: 6048810 · Received October 21, 2016

    Report

    Report Number
    3004962788-2016-00277
    Event Type
    Death
    Date Received
    October 21, 2016
    Date of Event
    June 14, 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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2016 FOR DECREASED APPETITE, RESPIRATORY DISTRESS, AND OVERALL FAILURE TO THRIVE. THE PATIENT WAS TRANSFERRED TO HOSPICE ON (B)(6) 2016 WHERE SHE SUBSEQUENTLY DIED OF RESPIRATORY FAILURE ON (B)(6) 2016. THE DEATH WAS REPORTED AS NOT RELATED TO ENB DEVICE OR INDEX PROCEDURE PERFORMED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698097 SUPERDIMENSION INREACH BRONCHUS SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death