BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 15218232 · Received August 12, 2022

    Report

    Report Number
    3004962788-2022-00064
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    February 14, 2022
    Report Date
    August 12, 2022
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE: PERCUTANEOUS THERMAL ABLATION THERAPY OF HEPATOCELLULAR CARCINOMA (HCC): MICROWAVE ABLATION (MWA) VERSUS LASER-INDUCED THERMOTHERAPY (LITT) SOURCE: DIAGNOSTICS 2022, 12, 564 ACCEPTED: 14 FEBRUARY 2022 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.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY COMPARED MICROWAVE ABLATION (MWA) WITH LASER-INDUCED THERMOTHERAPY (LITT) OF HEPATOCELLULAR CARCINOMA IN 250 PATIENTS. THE EMPRINT MICROWAVE ABLATION (MWA) SYSTEM WAS USED WITH ONE SERIOUS INJURY REPORTED: POST-INTERVENTIONAL HEMORRHAGIC PLEURAL EFFUSION TREATED WITH A THORACIC DRAIN IN WHICH THE PATIENTS NEEDED TO BE HOSPITALIZED FOR A LONGER TIME. TITLE: PERCUTANEOUS THERMAL ABLATION THERAPY OF HEPATOCELLULAR CARCINOMA (HCC): MICROWAVE ABLATION (MWA) VERSUS LASER-INDUCED THERMOTHERAPY (LITT) AUTHOR: HAMZAH DR. ADWAN DATE OF PUBLICATION: 14 FEBRUARY 2022

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2905895 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention| H