BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPRINT

    MDR report key: 10886627 · Received November 23, 2020

    Report

    Report Number
    3004962788-2020-00067
    Event Type
    Injury
    Date Received
    November 23, 2020
    Date of Event
    July 7, 2020
    Report Date
    November 23, 2020
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: IMAGE-GUIDED ABLATIVE THERAPIES FOR LUNG TUMORS SOURCE: LUNG CANCER - MODERN MULTIDISCIPLINARY MANAGEMENT, DOI: HTTP://DX.DOI.ORG/10.5772/INTECHOPEN.94216 PAGES 1-23. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED SINCE EARLY 2019, 45 PATIENTS HAVE UNDERGONE ENDOLUMINAL ABLATION WITH THE ABLATION CATHETER GUIDED BY THE SUPERDIMENSION NAVIGATION SYSTEM. TWO PATIENTS (4.4%) DEVELOPED A PNEUMOTHORAX REQUIRING CHEST TUBE DRAINAGE. POST-ABLATION REACTION AND FEVER OCCURRED IN 8.9%, MINOR HEMOPTYSIS IN 4.4%, AND PLEURAL EFFUSION IN 2.2%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348840 EMPRINT NEY COVIDIEN LP - SUPERDIMENSION INC CA108L1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other