BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 12014180 · Received June 16, 2021

    Report

    Report Number
    3004962788-2021-00057
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    July 3, 2020
    Report Date
    June 16, 2021
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: OLIGOMETASTATIC ADRENOCORTICAL CARCINOMA: THE ROLE OF IMAGE-GUIDED THERMAL ABLATION SOURCE: EUROPEAN RADIOLOGY (2020) 30:6958¿6964. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE SAFETY, EFFICACY, AND CLINICAL USEFULNESS OF IMAGE-GUIDED ABLATION OF LIVER AND LUNG METASTATES FROM ADRENOCORTICAL CARCINOMA (ACC) BETWEEN NOVEMBER 2000 TO SEPTEMBER 2017. THERE WERE THIRTY-TWO ACC METASTASES (4 LUNG AND 28 LIVER) FROM 16 PATIENTS WHO WERE TREATED WITH RADIOFREQUENCY ABLATION (RFA) OR MICROWAVE ABLATION (MWA). THE MWA PROCEDURES WERE PERFORMED WITH EITHER MEDTRONIC EMPRINT OR HS AMICA. ONE MAJOR ADVERSE EVENT RELATED OCCURRED: INTRAHEPATIC HEMATOMA WITH SUBSEQUENT RIGHT HEMOTHORAX WHICH REQUIRED THE PLACEMENT OF A CHEST TUBE. IT IS UNKNOWN WHETHER THE EMPRINT WAS USED DURING THIS PROCEDURE OR CONTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904877 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention