BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN EMPRINT ANTENNA

    MDR report key: 20108361 · Received August 30, 2024

    Report

    Report Number
    3006451981-2024-00123
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    December 18, 2019
    Report Date
    August 30, 2024
    Manufacturer
    COVIDIEN MEDICAL PRODUCTS
    Product Code
    NEY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). USE OF PERCUTANEOUS MICROWAVE ABLATION FOR THE TREATMENT OF BONE TUMORS: A RETROSPECTIVE STUDY OF CLINICAL OUTCOMES IN 47 PATIENTS. WU ET AL. CANCER IMAGING (2019) 19:87. HTTPS://DOI.ORG/10.1186/S40644-019-0275-8. PAGES 1-12. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A CLINICAL STUDY INVESTIGATED THE SHORT-TERM CLINICAL PERFORMANCE AND SAFETY OF MWA FOR THE TREATMENT OF BOTH BENIGN AND MALIGNANT BONE TUMORS AND TO EVALUATE THE SIGNIFICANCE OF THIS METHOD IN THE FIELD OF BONE TUMORS. BETWEEN (B)(6) 2015 AND (B)(6) 2018, 47 PATIENTS WITH BONE TUMORS WERE TREATED WITH EMPRINT MWA. ADVERSE EVENTS REPORTED INCLUDED THREE PATIENTS WITH THERMAL INJURY WHICH CAUSED MYOFASCIITIS WHICH AFFECTED THEIR WOUND HEALING. IT WAS UNKNOWN THE TREATMENT OR SEVERITY OF THESE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522408 UNKNOWN EMPRINT ANTENNA SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES NEY COVIDIEN MEDICAL PRODUCTS UNKNOWN EMPRINT ANTENNA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female