BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 24364551 · Received February 17, 2026

    Report

    Report Number
    1717344-2026-00260
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    November 21, 2025
    Report Date
    February 17, 2026
    Manufacturer
    COVIDIEN
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMBINED SINGLE-SESSION STEREOTACTIC BIOPSY AND MICROWAVE ABLATION OF PRIMARY AND SECONDARY LIVER TUMORS. LIANG ZHANG, ANTHONY NGU, LAURA SOPHIA KUPKE, VINZENZ MAYR, QUIRIN STROTZER, MORITZ BRANDENSTEIN, CHRISTIAN STROSZCZYNSKI, AND INGO EINSPIELER. BIOMEDICINES 2025, 13, 2865. PUBLISHED: 24 NOVEMBER 2025. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EVALUATED THE SAFETY, DIAGNOSTIC YIELD, AND ABLATION EFFICACY OF A SINGLE SESSION WORKFLOW COMBINING STEREOTACTIC PERCUTANEOUS CORE-NEEDLE BIOPSY IMMEDIATELY FOLLOWED BY MICROWAVE ABLATION FOR LIVER TUMORS. EMPRINT AND COMPETITOR DEVICES WERE USED FOR THE PROCEDURES. BETWEEN DECEMBER 1, 2021 AND MAY 31, 2025, 33 CONSECUTIVE PATIENTS WERE INCLUDED IN THIS RETROSPECTIVE STUDY WITH ONLY ONE COMPLICATION OCCURRING. ONE PATIENT DEVELOPED A LIVER ABSCESS ONE WEEK AFTER ABLATION, WHICH WAS SUCCESSFULLY TREATED WITH PERCUTANEOUS DRAINING AND ANTIBIOTICS. THIS EVENT WAS CLASSIFIED AS A MAJOR COMPLICATION (CIRSE GRADE 3) DUE TO THE NEED FOR ADDITIONAL THERAPY AND HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423505 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Hospitalization| R