BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVIDENT

    MDR report key: 8243273 · Received January 14, 2019

    Report

    Report Number
    1717344-2019-00074
    Event Type
    Injury
    Date Received
    January 14, 2019
    Date of Event
    July 2, 2013
    Report Date
    January 14, 2019
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    UDI-DI
    10884524001579
    PMA / PMN Number
    K072687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: MICROWAVE ABLATION OF PANCREATIC HEAD CANCER: SAFETY AND EFFICACY SOURCE: J VASCINTERV RADIOL 2013, VOLUME 24, (1513-1520) ARTICLE NUMBER: 10 DATE OF PUBLICATION: OCTOBER 2013. (B)(4). 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 FOR 12 MONTHS, 1 MONTH AFTER BEING TREATED WITH ABLATION,1 PATIENT EXHIBITED A PROGRESSIVE DISEASE, ONE PATIENT WAS TREATED PERCUTANEOUSLY HAD A GASTRODUODENAL ARTERY PSEUDOANEURYSM RELATED TO ESCHAR HEALING AND 1 HAD A MILD PANCREATITIS THAT REQUIRED DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36950 EVIDENT SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER VTGEN 10884524001579

    Patients

    Seq Age Sex Outcome Treatment
    1 Other