BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EMPRINT GENERATOR

    MDR report key: 21118513 · Received January 9, 2025

    Report

    Report Number
    1717344-2025-00053
    Event Type
    Malfunction
    Date Received
    January 9, 2025
    Date of Event
    February 12, 2024
    Report Date
    March 3, 2025
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2(AGE AT EVENT), A3A, B5, G3, RFR CODES WERE UPDATED. ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    CORRECTION: B5 ADDITIONAL INFORMATION: G3 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

    D10 CONCOMITANT PRODUCTS: UNK - EMPRINT GEN - UNKNOWN EMPRINT GENERATOR UNK EMPRINT ANT - UNKNOWN EMPRINT ANTENNA, LOT# UNKNOWN UNK EMPRINT ANT - UNKNOWN EMPRINT ANTENNA, LOT# UNKNOWN LITERATURE EVENTS: AUTHOR: CALVIN SZE HANG NG TITLE: SAFETY AND FEASIBILITY OF TRANSBRONCHIAL MICROWAVE ABLATION FOR SUBPLEURAL LUNG NODULES SOURCE: DOI: 10.1177/02184923241228323. 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, FROM MARCH 2019 TO NOVEMBER 2022, 77 PATIENTS WITH 82 LUNG NODULES WERE TREATED WITH TRANSBRONCHIAL MWA IN THE HYBRID OPERATING THEATER AND ULTIMATELY INCLUDED IN THIS ANALYSIS; INCLUDING FIVE PATIENTS WITH TWO LUNG NODULES ABLATED IN TWO SEPARATE OPERATIVE SESSION. IN TOTAL, 21 CASES (25.6%) OF POSTOPERATIVE COMPLICATIONS WERE REPORTED: PLEURAL EFFUSION (1/82) WAS MANAGED CONSERVATIVELY WITHOUT THE NEED FOR DRAINAGE, RIB FRACTURE (1/82), PLEURITIC PAIN (7/82), POST-ABLATION FEVER (2/82), HEMOPTYSIS (1/82) WHICH RESOLVES ON ITS OWN AND PHRENIC NERVE PALSY (1/82) WHERE THE PATIENT REMAINED ASYMPTOMATIC AND DID NOT REQUIRE ANY ADDITIONAL MANAGEMENT. NONE OF THE COMPLICATIONS MENTIONED IN THIS COHORT WERE DIRECTLY RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, FROM MARCH 2019 TO NOVEMBER 2022, 77 PATIENTS WITH 82 LUNG NODULES WERE TREATED WITH TRANSBRONCHIAL MWA IN THE HYBRID OPERATING THEATER AND ULTIMATELY INCLUDED IN THIS ANALYSIS; INCLUDING FIVE PATIENTS WITH TWO LUNG NODULES ABLATED IN TWO SEPARATE OPERATIVE SESSION. IN TOTAL, 21 CASES (25.6%) OF POSTOPERATIVE COMPLICATIONS WERE REPORTED: PLEURAL EFFUSION (1/82) WAS MANAGED CONSERVATIVELY WITHOUT THE NEED FOR DRAINAGE, RIB FRACTURE (1/82), PLEURITIC PAIN (7/82), POST-ABLATION FEVER (2/82), HEMOPTYSIS (1/82) WHICH RESOLVES ON ITS OWN AND PHRENIC NERVE PALSY (1/82) WHERE THE PATIENT REMAINED ASYMPTOMATIC AND DID NOT REQUIRE ANY ADDITIONAL MANAGEMENT.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, FROM (B)(6) 2019 TO (B)(6) 2022, 77 PATIENTS WITH 82 LUNG NODULES WERE TREATED WITH TRANSBRONCHIAL MWA IN THE HYBRID OPERATING THEATER AND ULTIMATELY INCLUDED IN THIS ANALYSIS; INCLUDING FIVE PATIENTS WITH TWO LUNG NODULES ABLATED IN TWO SEPARATE OPERATIVE SESSION. IN TOTAL, 21 CASES (25.6%) OF POSTOPERATIVE COMPLICATIONS WERE REPORTED: PLEURAL EFFUSION (1/82) WAS MANAGED CONSERVATIVELY WITHOUT THE NEED FOR DRAINAGE, RIB FRACTURE (1/82), PLEURITIC PAIN (7/82), POST-ABLATION FEVER (2/82), HEMOPTYSIS (1/82) WHICH RESOLVES ON ITS OWN AND PHRENIC NERVE PALSY (1/82) WHERE THE PATIENT REMAINED ASYMPTOMATIC AND DID NOT REQUIRE ANY ADDITIONAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325643 UNKNOWN EMPRINT GENERATOR SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MFG DC BOULDER UNKNOWN EMPRINT GENERATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male SEE H11