BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 22923133 · Received August 29, 2025

    Report

    Report Number
    3006451981-2025-00095
    Event Type
    Injury
    Date Received
    August 29, 2025
    Date of Event
    June 26, 2025
    Report Date
    August 29, 2025
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    NEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: ILS-1000-CS, ILS-1000-CS ILLUMISITE CONSOLE (SERIAL#:UNKNOWN), SDATSW01, SDATSW01 ACCESS TOOL STRAIGHT WIRE (LOT#:UNKNOWN), AAS00161-20, AAS00161-20 US SUPERD NAVIGATION SYSTEM (SERIAL#:UNKNOWN), UNK NEEDLE, UNKNOWN BIOPSY NEEDLE, (LOT#:UNKNOWN) UNK EWC, UNKNOWN EXTENDED WORKING CHANNEL (LOT#:UNKNOWN) UNK EMPRINT ANT, UNKNOWN EMPRINT ANTENNA (LOT#:UNKNOWN), ILS-1000-CS, ILS-1000-CS ILLUMISITE CONSOLE (SERIAL#:UNKNOWN), SDATSW01, SDATSW01 ACCESS TOOL STRAIGHT WIRE (LOT#:UNKNOWN), AAS00161-20, AAS00161-20 US SUPERD NAVIGATION SYSTEM (SERIAL#:UNKNOWN), UNK NEEDLE, UNKNOWN BIOPSY NEEDLE (LOT#:UNKNOWN), UNK EWC, UNKNOWN EXTENDED WORKING CHANNEL (LOT#:UNKNOWN) ALISS T.C. CHANG, JOYCE W.Y. CHAN, IVAN C.H. SIU, RAINBOW W.H. LAU, CHEUK MAN CHU, TONY S.K. MOK, AND CALVIN S.H. NG. "HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION." INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY 2025, 40(7), IVAF152. HTTPS://DOI.ORG/10.1093/ICVTS/IVAF152 ADVANCE ACCESS PUBLICATION 27 JUNE 2025 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 SOURCE OF STUDY PERFORMED BETWEEN MARCH 2019 TO FEBRUARY 2024, A RETROSPECTIVE STUDY ANALYZED THE HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION WITH CONCOMITANT VIDEO-ASSISTED THORACOSCOPIC LUNG RESECTION. A TOTAL OF 92 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 103 PROCEDURES PERFORMED AND 162 LUNG NODULES TREATED 142 LUNG NODULES WERE ABLATED AND 20 LUNG NODULES WERE RESECTED. THREE CASES OF GRADE 2 COMPLICATIONS WERE REPORTED, INCLUDING ONE INSTANCE OF PERSISTENT FEVER AND TWO CASES OF AIRWAY BLEEDING, WHICH REQUIRED THE USE OF ORAL ANTIBIOTICS. ADDITIONALLY, THREE CASES OF GRADE 3 COMPLICATIONS WERE OBSERVED: TWO CASES OF PNEUMOTHORAX REQUIRING CHEST TUBE DRAINAGE, AND ONE CASE OF BRONCHOPLEURAL FISTULA REQUIRING ENDOBRONCHIAL VALVE PLACEMENT. TWO COMPLICATIONS LED TO HOSPITAL READMISSION DUE TO PERSISTENT FEVER AND DELAYED PNEUMOTHORAX. HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION. DR. CALVIN NG, 2025, INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2887523 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MEDICAL PRODUCTS UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention SEE H11