BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA AV

    MDR report key: 21245733 · Received January 27, 2025

    Report

    Report Number
    9612164-2025-00432
    Event Type
    Injury
    Date Received
    January 27, 2025
    Date of Event
    January 1, 2024
    Report Date
    January 27, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. THIS EVENT OCCURRED OUTSIDE THE US. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE EVENT ONLY OCCURRED WITH ONE PATIENT BUT SPECIFIC DETAILS ON THE PATIENT WERE NOT PROVIDED. 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: TRICUSPID VALVE COMPLICATION FOLLOWING LEADLESS PACEMAKER IMPLANTATION REQUIRING DEVICE EXTRACTION. HEART RHYTHM CASE REPORTS. 2024; 10:960¿962. DOI: 10.1016/J.HRCR.2024.09.012 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 TRICUSPID VALVE COMPLICATION FOLLOWING LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION. THE AUTHORS DESCRIBED A PATIENT WHO PRESENTED THREE YEARS AFTER IMPLANT WITH DYSPNEA ON EXERTION. CORONARY ANGIOGRAPHY REVEALED SEVERE MULTIVESSEL DISEASE, AND THE PATIENT WAS REFERRED FOR CORONARY ARTERY BYPASS GRAFTING. IT WAS NOTED THAT THE LEADLESS IPG WAS INADVERTENTLY IMPLANTED INTO THE TRICUSPID VALVE SUB VALVULAR APPARATUS CAUSING TETHERING OF THE SEPTAL TV LEAFLET, WHICH LED TO SEVERE TRICUSPID REGURGITATION (TR). FOLLOWING SUCCESSFUL CORONARY ARTERY BYPASS GRAFTING, THE LEADLESS IPG WAS EXTRACTED. THE PATIENT WAS THEN IMPLANTED WITH A TRANSVENOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771094 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R