BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA

    MDR report key: 22016892 · Received May 14, 2025

    Report

    Report Number
    9612164-2025-02391
    Event Type
    Death
    Date Received
    May 14, 2025
    Date of Event
    April 22, 2025
    Report Date
    June 16, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE INTRODUCER WAS RETURNED AND ANALYZED. RETURNED PRODUCT ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE ANALYST NOTED THE INTRODUCER WAS RETURNED WITH THE DILATOR FULLY INSERTED IN THE SHEATH OF THE INTRODUCER. 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

    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 DURING THE IMPLANT PROCEDURE THE INTRODUCER WAS INSERTED AND THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DELIVERY SYSTEM (DS) WAS INSERTED THROUGH THE INTRODUCER. THE PATIENT STOPPED RESPONDING AND THE PHYSICIAN STOPPED THE PROCEDURE. RESCUE EFFORTS WERE MADE WITH CARDIOPULMONARY RESUSCITATION, DEFIBRILLATION AND MASSAGE PERFORMED, HOWEVER THE PATIENT HAD A STROKE AND PASSED AWAY. THE LEADLESS IPG DS AND INTRODUCER WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967930 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A P2F24K0055

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Death