BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION BRONCHUS SYSTEM (SDBS)

    MDR report key: 1131203 · Received August 20, 2008

    Report

    Report Number
    3004962788-2008-00015
    Event Type
    Death
    Date Received
    August 20, 2008
    Date of Event
    July 22, 2008
    Report Date
    August 20, 2008
    Manufacturer
    SUPERDIMENSION, LTD.
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MALE, WITH PERMANENT STOMA, AND HISTORY OF THROAT CANCER DIED 4 DAYS POST-PROCEDURE. A SUPERDIMENSION PROCEDURE WAS CONDUCTED, AND DURING NAVIGATION, A PNEUMOTHORAX WAS OBSERVED, AND THE PROCEDURE DISCONTINUED. A CHEST TUBE WAS INSERTED, AND PER THE PHYSICIAN, THE PT WAS EXPECTED TO RECOVER. THE SOURCE OF THE PNEUMOTHORAX IS NOT DEFINITIVELY UNDERSTOOD, AND PER THE PHYSICIAN, IT IS LIKELY THE PT DIED OF SEPSIS AS A COMPLICATION OF THE PNEUMOTHORAX. NO FURTHER INFO OR KNOWN CAUSE OF DEATH, COULD BE OBTAINED FROM THE SITE. AT NO TIME DID THE PHYSICIAN FIND FAULT WITH OR SPECULATE THAT THE INREACH SYS MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERDIMENSION BRONCHUS SYSTEM (SDBS) COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK SUPERDIMENSION, LTD. * S030104

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death