BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 6050764 · Received October 24, 2016

    Report

    Report Number
    3004962788-2016-00278
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 29, 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) 2015. THE PATIENT DIED ON (B)(6) 2016. NO FURTHER DETAILS ARE KNOWN HOWEVER, 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
    702387 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY JAK SUPERDIMENSION INC. AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death