BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERDIMENSION INREACH SYSTEM

    MDR report key: 3947322 · Received July 11, 2014

    Report

    Report Number
    3004962788-2014-00035
    Event Type
    Death
    Date Received
    July 11, 2014
    Date of Event
    June 13, 2014
    Report Date
    July 11, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE IS UNDER EVALUATION. WHEN THE DEVICE EVALUATION IS COMPLETE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER ORIGINALLY REPORTED THE PATIENT STARTED BLEEDING WHILE NAVIGATING DURING A SUPERDIMENSION PROCEDURE ON (B)(6) 2014. THE CASE WAS CANCELLED AND THE PATIENT WAS MOVED TO ICU. THERE WAS NO SYSTEM MALFUNCTION AND THE CUSTOMER REPORTED THE SYSTEM DID NOT CONTRIBUTE TO THE PATIENT'S BLEEDING. IN ADDITION, ON (B)(6) 2014, THE PATIENT SUFFERED A ISCHEMIC STROKE WHILE HOSPITALIZED. THE PATIENT SUBSEQUENTLY EXPIRED FROM A BLOOD CLOT IN THE HOSPITAL ON (B)(6) 2014. IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405802 SUPERDIMENSION INREACH SYSTEM ELECTROMAGNETIC NAVIGATION BRONCHOS JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Death