BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6244404 · Received January 11, 2017

    Report

    Report Number
    3004962788-2017-00003
    Event Type
    Death
    Date Received
    January 11, 2017
    Date of Event
    October 14, 2016
    Report Date
    December 15, 2016
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    A PATIENT HAD A SUPERDIMENSION ENB PROCEDURE ON (B)(6) 2016. THE PATIENT WENT TO THE HOSPITAL ON (B)(6) 2016 WITH SYMPTOMS OF WEAKNESS AND DIZZINESS S/P RADIATION AND CHEMOTHERAPY. HE WAS ADMITTED WITH HYPOTENSION, ACUTE KIDNEY INJURY, AND HYPOXIA. HE LATER EXPERIENCED CARDIOPULMONARY ARREST AND DIED ON (B)(6) 2016. 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
    26943 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death