BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT GENERATOR

    MDR report key: 18196913 · Received November 22, 2023

    Report

    Report Number
    3004962788-2023-00131
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    August 31, 2023
    Report Date
    November 22, 2023
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNK EMPRINT ANT - UNKNOWN EMPRINT ANTENNA, LOT# UNKNOWN UNK - EMPRINT GEN - UNKNOWN EMPRINT GENERATOR, SERIAL# UNKNOWN LITERATURE EVENTS: AUTHOR:MADELON DIJKSTRA 1, SUSAN VAN DER LEI 1, ROBBERT S. PUIJK 1, HANNAH H. SCHULZ 1, DANIELLE J. W. VOS 1 FLORENTINE E. F. TIMMER 1, HESTER J. SCHEFFER 1,2, TINEKE E. BUFFART 3, M. PETROUSJKA VAN DEN TOL 4 BIRGIT I. LISSENBERG-WITTE 5, RUTGER-JAN SWIJNENBURG 6, KATHELIJN S. VERSTEEG 3 AND MARTIJN R. MEIJERINK TITLE: EFFICACY OF THERMAL ABLATION FOR SMALL-SIZE (0¿3 CM) VERSUS INTERMEDIATE-SIZE (3¿5 CM) COLORECTAL LIVER METASTASES: RESULTS FROM THE AMSTERDAM COLORECTAL LIVER MET REGISTRY (AMCORE) SOURCE: HTTPS:// DOI.ORG/10.3390/ CANCERS15174346 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, THE PROSPECTIVELY MAINTAINED AMSTERDAM COLORECTAL LIVER MET REGISTRY DATABASE WAS USED TO ANALYZE THE EFFICACY OF THERMAL ABLATION FOR SMALL-SIZE VERSUS INTERMEDIATE SIZE COLORECTAL LIVER METASTASES (CRLM). BETWEEN DECEMBER OF 2000 AND NOVEMBER OF 2021, 280 PATIENTS WERE INCLUDED WHILE UNDERGOING 347 PROCEDURES WITH 856 CRLM USING COOL-TIP, EMPRINT SYSTEM, EVIDENT SYSTEM, AND COMPETITOR¿S DEVICES. THE COMPLICATION RATE WAS 33/221 (14.9%) OF PATIENTS WITH SMALL-SIZE CRLM AND 9/59 (15.3%) OF PATIENTS WITH INTERMEDIATE-SIZE CRLM. ONE PATIENT IN THE INTERMEDIATE-SIZED GROUP HAD A GRADE 4 COMPLICATION FOLLOWING OPEN THERMAL ABLATION: POST-PROCEDURAL ILEUS AND ASPIRATION PNEUMONIA WITH STAPHYLOCOCCUS AUREUS BACTEREMIA REQUIRING INTENSIVE CARE UNIT ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041960 UNKNOWN EMPRINT GENERATOR SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Other