BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 23537471 · Received November 12, 2025

    Report

    Report Number
    9612164-2025-05594
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    January 1, 2025
    Report Date
    November 12, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. THE MODEL LISTED IN THE REPORT IS A REPRESENTATIVE OF THE MODEL FAMILY, AS THERE IS NO SPECIFIC MODEL LISTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: ANESTHETIC MANAGEMENT OF INTRACARDIAC MIGRATION OF MEDICAL DEVICES. JOURNAL OF CARDIOTHORACIC AND VASCULAR ANESTHESIA. 2025. 39: 1866-1877. DOI: 10.1053/J.JVCA.2024.07.015 THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME: MICRA PRODUCT ID: MDT-TPS-DELSYS SERIAL: UNKNOWN D9: NO 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

    LITERATURE WAS REVIEWED REGARDING MIGRATION OF MEDICAL DEVICES. THE AUTHORS DESCRIBED A PATIENT WHO UNDERWENT THE IMPLANT OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). DURING THE UNTETHERING OF THE DEVICE, THE LEADLESS IPG DISLODGED AND MIGRATED TO THE RIGHT PULMONARY ARTERY. THERE WAS BRIEF DECOMPENSATION, AND EXTERNAL PACING WAS REQUIRED WITH A DOPAMINE INFUSION FOR SYMPTOMATIC BRADYCARDIA. THE LEADLESS IPG WAS SNARED AND EXTRACTED. A CONVENTIONAL SUBCUTANEOUS PERMANENT IPG WAS IMPLANTED. THE STATUS OF THE LEADLESS DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2034221 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MDT-TPS-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female Required Intervention| H