BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3928573 · Received June 27, 2014

    Report

    Report Number
    3004962788-2014-00034
    Event Type
    Death
    Date Received
    June 27, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 27, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS BEEN RECEIVED AND IS UNDER EVAL. WHEN THE DEVICE EVAL IS COMPLETE A F/U REPORT WILL BE SUBMITTED. PNEUMOTHORAX IS A KNOWN SHORT TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THAT DURING A SUPERDIMENSION PROCEDURE ON (B)(6) 2014, THE SYSTEM SHUT DOWN UNEXPECTEDLY. IN ADDITION, THE PT SUSTAINED A PNEUMOTHORAX DURING THIS PROCEDURE BUT THE SITE STATED THE SYSTEM SHUT DOWN DID NOT CONTRIBUTE TO THE PT'S PNEUMOTHORAX. THE PT SUBSEQUENTLY EXPIRED IN THE HOSP ON (B)(6) 2014. ADD'L QUESTIONS HAVE BEEN EXTENDED TO THE SITE, IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376771 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNITIC NAVIGATION BRONCHOS JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death