BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA

    MDR report key: 23495200 · Received November 7, 2025

    Report

    Report Number
    9612164-2025-05484
    Event Type
    Death
    Date Received
    November 7, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 7, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    UDI-DI
    00643169964594
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION, THE PHYSICIAN EXPERIENCED SIGNIFICANT DIFFICULTY ADVANCING THE DELIVERY SYSTEM (DS) INTO THE RIGHT VENTRICLE (RV) DUE TO THE PATIENT¿S COMPLEX CARDIAC ANATOMY. AFTER SEVERAL ATTEMPTS, HE WAS FINALLY ABLE TO ADVANCE THE DS INTO THE RV AND IDENTIFY A POTENTIAL TARGET AREA. ECHOCARDIOGRAPHIC EVALUATION CONFIRMED A PERICARDIAL EFFUSION/CARDIAC TAMPONADE, PERFORATION AND A PERICARDIOCENTESIS WAS PERFORMED. DESPITE CONTINUOUS ACTIVE DRAINAGE, PHARMACOLOGICAL THERAPY AND RESUSCITATION EFFORTS, THE PATIENT ULTIMATELY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171045 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A P2F25H0020 00643169964594

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death MC1VR01.