BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERDIMENSION

    MDR report key: 21124944 · Received January 10, 2025

    Report

    Report Number
    3004962788-2025-00009
    Event Type
    Injury
    Date Received
    January 10, 2025
    Date of Event
    September 4, 2024
    Report Date
    January 10, 2025
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    JAK
    UDI-DI
    10884521199989
    PMA / PMN Number
    K151376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PNEUMOTHORAX IS A KNOWN SHORT-TERM COMPLICATION WHEN A LUNG BIOPSY IS PERFORMED DURING A TRANSBRONCHIAL LUNG BIOPSY OR CT GUIDED PERCUTANEOUS BIOPSY. ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY-GUIDED PREOPERATIVE LUNG NODULE LOCALIZATION IN VIDEO-ASSISTED THORACIC SURGERY (VATS): A LEARNING CURVE ANALYSIS; JINBO ZHAO; TRANSLATION LUNG CANCER RESEARCH 2024;13(10):2561-2572 / HTTPS://DX.DOI.ORG/10.21037/TLCR-24-337 / PUBLISHED ONLINE OCT 28, 2024. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO LITERATURE, A RETROSPECTIVE STUDY ANALYZED THE LEARNING CURVE OF ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) IN PATIENTS WITH SMALL PERIPHERAL PULMONARY NODULES BETWEEN NOVEMBER 2019 AND DECEMBER 2021. SUPERDIMENSION WAS USED TO RECONSTRUCT THE VIRTUAL BRONCHUS RECONSTRUCTION AND IDENTIFY THE PATHWAY TO THE TARGET LESION. COMPLICATIONS RELATED TO THE ENB PROCEDURE INCLUDED PNEUMOTHORAX IN TWO PATIENTS. INTERVENTIONS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367165 SUPERDIMENSION SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED JAK COVIDIEN LP - SUPERDIMENSION INC AAS00161-20 10884521199989

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Other