BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18659276 · Received February 7, 2024

    Report

    Report Number
    1723170-2024-00465
    Event Type
    Death
    Date Received
    February 7, 2024
    Date of Event
    October 30, 2020
    Report Date
    February 27, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G2: THIS EVENT OCCURRED IN (B)(6), H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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 · 0

    H2) ADDITIONAL INFORMATION WAS ADDED TO B5. 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

    CITATION: EUROPEAN RADIOLOGY (2021) 31:3042¿3052 HTTPS://DOI.ORG/10.1007/S00330-020-07409-0 SUMMARY: OBJECTIVES: TO ASSESS THE FREQUENCY OF MAJOR COMPLICATIONS AFTER MULTI-PROBE STEREOTACTIC RADIOFREQUENCY ABLATION (SRFA) IN A LARGE COHORT OF PATIENTS OVER 15 YEARS AND TO ELUCIDATE RISK FACTORS FOR ADVERSE EVENTS. MATERIALS AND METHODS: A RETROSPECTIVE STUDY WAS CARRIED OUT BETWEEN JULY 2003 AND DECEMBER 2018. SEVEN HUNDRED NINETY-THREE CONSECUTIVE PATIENTS (MEDIAN 65.0 YEARS (0.3¿88), 241 WOMEN AND 552 MEN, WERE TREATED IN 1235 SRFA SESSIONS FOR 2475 PRIMARY AND METASTATIC LIVER TUMORS WITH A MEDIAN TUMOR SIZE OF 3.0 CM (0.5¿18 CM). THE FREQUENCY OF MAJOR COMPLICATIONS WAS EVALUATED ACCORDING TO SIR GUIDELINES AND PUTATIVE PREDICTORS OF ADVERSE EVENTS ANALYZED USING SIMPLE AND MULTIVARIABLE LOGISTIC REGRESSION. RESULTS: THIRTY-DAY MORTALITY AFTER SRFA WAS 0.5% (6/1235) WITH AN OVERALL MAJOR COMPLICATION RATE OF 7.4% (91/1235). THE MAJOR COMPLICATION RATE DECREASED FROM 11.5% (36/314) (BEFORE JANUARY 2011) TO 6.0% (55/921) (P = 0.001). 50.5% (46/91) OF MAJOR COMPLICATIONS WERE SUCCESSFULLY TREATED IN THE SAME ANESTHETIC SESSION BY ANGIOGRAPHIC COILING FOR HEMORRHAGE AND CHEST TUBE INSERTION FOR PNEUMOTHORAX. HISTORY OF BILE DUCT SURGERY/INTERVENTION, NUMBER OF COAXIAL NEEDLES, AND LOCATION OF TUMORS IN SEGMENT IVA OR VIII WERE INDEPENDENT PROGNOSTIC FACTORS FOR MAJOR COMPLICATIONS FOLLOWING MULTIVARIABLE LOGISTIC REGRESSION ANALYSIS. SIMPLE LOGISTIC REGRESSION REVEALED THE NUMBER OF TUMORS, TUMOR SIZE, LOCATION CLOSE TO THE DIAPHRAGM, TUMOR CONGLOMERATE, AND SEGMENT VII AS OTHER SIGNIFICANT PREDICTORS. CONCLUSION: SRFA OF LIVER TUMORS IS SAFE AND CAN EXTEND THE TREATMENT SPECTRUM OF CONVENTIONAL REPORTED EVENTS: THIS WAS A RETROSPECTIVE STUDY WAS CARRIED OUT BETWEEN JULY 2003 AND DECEMBER 2018. SEVEN HUNDRED NINETY-THREE CONSECUTIVE PATIENTS (MEDIAN 65.0 YEARS (0.3¿88), 241 WOMEN AND 552 MEN, WERE TREATED IN 1235 SRFA SESSIONS FOR 2475 PRIMARY AND METASTATIC LIVER TUMORS WITH A MEDIAN TUMOR SIZE OF 3.0 CM (0.5¿18 CM). THIRTY-DAY MORTALITY WAS 0.5% (6/1235) WITH FOUR DEATHS OCCURRING FROM MAJOR HEMORRHAGE, ONE DUE TO SEPSIS, AND ONE AS A CONSEQUENCE OF ACUTE-ON-CHRONIC RENAL FAILURE.

    Description of Event or Problem · 0

    THE HEALTH CARE PROFESSIONAL STATED THAT "I HEREWITH CONFIRM THAT NONE OF THE ADVERSE EVENTS REPORTED WERE DIRECTLY RELATED TO ANY MEDTRONIC DEVICE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1792962 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Death