BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN COOL TIP ELECRTRODE

    MDR report key: 19146609 · Received April 19, 2024

    Report

    Report Number
    1717344-2024-00994
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    December 27, 2023
    Report Date
    April 29, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE EVENTS: AUTHOR: KAZUKI MURAI, MD, PHD, AKIRA YAMAMOTO, MD, PHD*, KEN KAGEYAMA, MD, PHD,MARIKO NAKANO, MD, PHD, ATSUSHI JOGO, MD, PHD, YUKIO MIKI, MD, PHD TITLE: A CASE OF RECURRENT LARYNGEAL NERVE PARALYSIS CAUSED BY RADIOFREQUENCY ABLATION FOR MEDIASTINAL RECURRENCE OF LUNG CANCER. SOURCE: HTTPS://DOI.ORG/10.1016/J.RADCR.2023.12.059 / 1930-0433/© 2023 THE AUTHORS. PUBLISHED BY ELSEVIER INC. ON BEHALF OF UNIVERSITY OF WASHINGTON. THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/) MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, G3, RFR AND FDP CODES WERE UPDATED CORRECTION: E1(INITIAL REPORTER WAS REMOVED), E3 WAS REMOVED NEW INFORMATION HAS BEEN RECEIVED, AND REASSESSMENT OF THE COMPLAINT FOUND THAT IT IS NO LONGER A REPORTABLE ISSUE. THE EVENT IS NO LONGER ASSOCIATED WITH A SERIOUS INJURY OR POTENTIAL FOR SERIOUS INJURY WITH REOCCURRENCE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, AN ARTICLE REPORTED A CASE WHERE A RADIOFREQUENCY ABLATION (RFA) WAS PERFORMED USING A COOL-TIP 2-CM ELECTRODE FOR THE TREATMENT OF A LOCALLY RECURRENT LUNG CANCER LESION IN THE MEDIASTINUM NEAR THE AORTIC ARCH. ONE MONTH AFTER THE TREATMENT, IT WAS REPORTED THAT THE PATIENT DEVELOPED A HOARSENESS OF BREATH. LARYNGOSCOPY REVEALED FIXATION OF THE LEFT VOCAL CORD, CONSISTENT WITH A DIAGNOSIS OF LEFT RECURRENT LARYNGEAL NERVE PALSY. DURING THE FOLLOW-UP FOR SEVEN MONTHS, THERE WERE NO SIGNS OF INFECTION AND THE LESION DID NOT REGROW, HOWEVER, THERE WAS ONLY A SLIGHT IMPROVEMENT IN SYMPTOMS AND THE HOARSENESS OF BREATH REMAINED.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, AN ARTICLE REPORTED A CASE WHERE A RADIOFREQUENCY ABLATION (RFA) WAS PERFORMED USING A COOL-TIP 2-CM EL ECTRODE FOR THE TREATMENT OF A LOCALLY RECURRENT LUNG CANCER LESION IN THE MEDIASTINUM NEAR THE AORTIC ARCH. ONE MONTH AFTER THE TREATMENT, IT WAS REPORTED THAT THE PATIENT DEVELOPED A HOARSENESS OF BREATH. LARYNGOSCOPY REVEALED FIXATION OF THE LEFT VOCAL CORD, CO NSISTENT WITH A DIAGNOSIS OF LEFT RECURRENT LARYNGEAL NERVE PALSY. DURING THE FOLLOW-UP FOR SEVEN MONTHS, THERE WERE NO SIGNS OF INFECTION AND THE LESION DID NOT REGROW, HOWEVER, THERE WAS ONLY A SLIGHT IMPROVEMENT IN SYMPTOMS AND THE HOARSENESS OF BREATH REMAINED. OF THE ADVERSE EVENTS THAT WERE MENTIONED WITHIN THIS ARTICLE, NONE OF THEM RELATE DIRECTLY TO THE MEDTRONIC DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685842 UNKNOWN COOL TIP ELECRTRODE ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN COOL TIP ELECRTRODE

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown