BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 21401119 · Received February 18, 2025

    Report

    Report Number
    9612164-2025-00878
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    December 16, 2024
    Report Date
    February 18, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    PMA / PMN Number
    K132030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS MALE/79 YEARS OLD. 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: JUGULAR VASCULAR CLOSURE AND SCAR FORMATION AFTER LEADLESS PACEMAKER IMPLANTATION. REVIEWS IN CARDIOVASCULAR MEDICINE. 2024; 25(12): 440 DOI: 10.31083/J.RCM2512440, 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING JUGULAR VASCULAR CLOSURE AND SCAR FORMATION AFTER LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) IMPLANTATION. THE AUTHORS DESCRIBED ONE PATIENT WHO EXPERIENCED A MINOR HEMATOMA WHICH REQUIRED LIGHT MANUAL PRESSURE FOR TEN MINUTES. THERE WAS ALSO ONE DEVICE WHICH EXHIBITED A THRESHOLD RISE AND RESOLVED WITH REPROGRAMMING. THE DEVICES REMAIN IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2641868 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention