BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION INREACH SYS

    MDR report key: 4092449 · Received September 4, 2014

    Report

    Report Number
    3004962788-2014-00047
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 6, 2014
    Report Date
    October 23, 2014
    Manufacturer
    SUPERDIMENSION INC.
    Product Code
    JAK
    PMA / PMN Number
    K092365
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUPERDIMENSION HAS REQUESTED THE DEVICE FROM THE SITE BUT HAS NOT RECEIVED ANYTHING FOR EVALUATION TO DATE. IF ADDITIONAL INFO IS RECEIVED A FOLLOW-UP 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPONENT OF THE SUPERDIMENSION SYSTEM; CASE RECORDINGS WERE RETURNED AND THE EVALUATION OF THE RECORDINGS SHOWED CT TO BODY DIVERGENCE IN THE AUTOMATIC REGISTRATION. HOWEVER, THERE WAS NO EVIDENCE OF THE PNEUMOTHORAX, THEREFORE NO CONCLUSION CAN BE DRAWN. THERE WERE NO ANOMALIES IDENTIFIED DURING THE INTERNAL REVIEW OF THE DHR OF THE SYSTEM CONSOLE.

    Description of Event or Problem · 1

    A PT RECEIVED A PNEUMOTHORAX AFTER A SUPERDIMENSION PROCEDURE. A URESIL THORACIC VENT DEVICE WAS PLACED AND THE PT WENT HOME. PT WAS SEEN THE NEXT DAY AND THE DEVICE WAS REMOVED. IF ADDITIONAL INFO PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542134 SUPERDIMENSION INREACH SYS ELECTROMAGNETIC NAVIGATION BRONCHOS JAK SUPERDIMENSION INC. AAS00161-20

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other| R