BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC HEART VALVE

    MDR report key: 23654452 · Received November 26, 2025

    Report

    Report Number
    2025587-2025-05975
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    April 12, 2020
    Report Date
    November 26, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    UDI-DI
    00613994689139
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID FR995-21 (B081396); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2014; 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

    IT WAS REPORTED THAT 6 YEARS POST IMPLANT OF THIS 25MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1946451 MOSAIC MITRAL BIOPROSTHETIC HEART VALVE REPLACEMENT HEART-VALVE DYE MEDTRONIC HEART VALVES DIVISION 310C25 00613994689139

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Hospitalization| L| R