BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA

    MDR report key: 23529980 · Received November 12, 2025

    Report

    Report Number
    2953200-2025-00017
    Event Type
    Death
    Date Received
    November 12, 2025
    Date of Event
    October 17, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: MC2AVR1 LEADLESS IPG WAS IMPLANTED ON (B)(6) 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

    IT WAS REPORTED BY THE PATIENT DAUGHTER THAT THE PATIENT PASSED AWAY SHORTLY AFTER THE IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM POSSIBLY RELATED TO THE COMPLICATIONS DURING TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2645324 MICRA INTRODUCER, CATHETER DYB MEDTRONIC VASCULAR MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death "SEE H11...."