BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EVIDENT GENERATOR

    MDR report key: 16285866 · Received February 2, 2023

    Report

    Report Number
    3004962788-2023-00010
    Event Type
    Malfunction
    Date Received
    February 2, 2023
    Date of Event
    September 4, 2022
    Report Date
    February 2, 2023
    Manufacturer
    COVIDIEN LP - SUPERDIMENSION INC
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: UNK - EVIDENT GEN, UNKNOWN EVIDENT GENERATOR (SERIAL#: UNKNOWN); UNK - EVIDENT GEN, UNKNOWN EVIDENT GENERATOR (SERIAL#: UNKNOWN) TITLE: TRANSARTERIAL RADIOEMBOLIZATION VERSUS TRANSARTERIAL CHEMOEMBOLIZATION PLUS PERCUTANEOUS ABLATION FOR UNRESECTABLE, SOLITARY HEPATOCELLULAR CARCINOMA OF >3CM: A PROPESITY SCORE-MATCHED STUDY. SOURCE: JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY 2022;33 :1570-1577 PUBLICATION DATE: SEPTEMBER 12, 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 SOURCE OF STUDY PERFORMED BETWEEN 2008 TO 2021, A RETROSPECTIVE STUDY ANALYZED THE OUTCOMES OF 69 PATIENTS WITH TREATMENT-NAÏVE SOLITARY HEPATOCELLULAR CARCINOMA (HCC) OF GREATER THAN 3 CM WHO UNDERWENT EITHER TRANSARTERIAL CHEMO-EMBOLIZATION (TACE) PLUS THERMAL ABLATION OR TRANSARTERIAL RADIO-EMBOLIZATION. THERMAL ABLATION WAS PERFORMED WITH EITHER THE EVIDENT MICROWAVE ABLATION SYSTEM OR COMPETITOR DEVICE. NON-SERIOUS INJURY INCLUDED PAIN TREATED WITH PAIN MEDICATIONS. THE STUDY ALSO REPORTS DEATHS THAT ARE UNRELATED TO THE DEVICE. THE ARTICLE DOES NOT SPECIFY WHICH DEVICE WAS ASSOCIATED WITH THE REPORTED ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381103 UNKNOWN EVIDENT GENERATOR SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EVIDENT GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female SEE NOTE ON H10