BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 24252468 · Received February 3, 2026

    Report

    Report Number
    2182208-2026-01617
    Event Type
    Injury
    Date Received
    February 3, 2026
    Date of Event
    February 15, 2025
    Report Date
    February 3, 2026
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN
    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: MICRA LEADLESS PACEMAKER IMPLANTATION VIA TRANSJUGULAR APPROACH. JOURNAL OF THE HONG KONG COLLEGE OF CARDIOLOGY. 2025. 31(6):145-148. DOI: 10.55503/2790-6744.1546 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 A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION VIA THE TRANSJUGULAR APPROACH. THE AUTHORS DESCRIBED A PATIENT WHO EXPERIENCED A MILD HEMATOMA WITH SURROUNDING ECCHYMOSIS AT THE ACCESS SITE POST-PROCEDURE. THE HEMATOMA WAS MANAGED CONSERVATIVELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307739 MICRA INTRODUCER, CATHETER DYB MEDTRONIC, INC. MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention