BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN RF ELECTRODE

    MDR report key: 9840708 · Received March 17, 2020

    Report

    Report Number
    1717344-2020-00301
    Event Type
    Death
    Date Received
    March 17, 2020
    Date of Event
    January 1, 2018
    Report Date
    April 9, 2020
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). (TRANSIENT PULMONARY FAILURE, BILATERAL EFFUSIN, PLEURAL EFFUSION, THORACENTESES,PNEUMOTHORACES) TITLE FEASIBILITY, SAFETY, AND LONG-TERM EFFICACY OF STEREOTATIC RADIOFREQUENCY ABLATION FOR TUMORS ADJACENT TO THE DIAPHRAGM IN THE HEPATIC DOME: A CASE-CONTROL STUDY SOURCE EUROPEAN RADIOLOGY, VOLUME 30, 2020 (950-960) DATE OF PUBLICATION ONLINE: 5 SEPTEMBER 2019. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE STUDY PERFORMED, 891 CONSECUTIVE PATIENTS WERE TREATED BY STEREOTACTIC RF ABLATION (SRFA). A TOTAL OF 177 OF THESE PATIENTS WITH HEPATIC DOME TUMORS WERE SELECTED BY USING A NEAREST NEIGHBOR PROPENSITY SCORE FOR THIS RETROSPECTIVE STUDY. A MEDIAN OF 2 TUMORS (1¿11) WERE TREATED PER ABLATION SESSION (IN TOTAL 204 SESSIONS), INCLUDING 111 PATIENTS (62.7%) WITH ADDITIONAL TUMORS OUTSIDE OF THE HEPATIC DOME. THE TOTAL MAJOR COMPLICATION RATE WAS 12.3% (25 OF 204). OUT OF 177 PATIENTS, 1 DEATH OCCURRED FOLLOWING ABLATION OF COLORECTAL LIVER METASTASIS DUE TO MAJOR BLEEDING. ¿SRFA WAS SUCCESSFULLY COMPLETED ACCORDING TO PLAN IN ALL 238 TUMORS (TECHNICAL SUCCESS RATE 100%).¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304838 UNKNOWN RF ELECTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN MFG DC BOULDER UNKNOWN RF ELECTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| O