BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA AV

    MDR report key: 24416216 · Received February 23, 2026

    Report

    Report Number
    9612164-2026-00968
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    April 21, 2025
    Report Date
    February 23, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. 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/75 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: INCIDENCE OF PACING-INDUCED CARDIOMYOPATHY: LEFT BUNDLE BRANCH AREA PACING VERSUS LEADLESS PACING. JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2025. 68:1585¿1592. DOI: 10.1007/S10840-025-02048-1. 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 PACING-INDUCED CARDIOMYOPATHY IN LEFT BUNDLE BRANCH AREA PACING VERSUS LEADLESS PACING. THE AUTHORS DESCRIBED PATIENTS IN BOTH GROUPS WHO EXPERIENCED HEART FAILURE HOSPITALIZATIONS AND PACING-INDUCED CARDIOMYOPATHY. SOME PATIENTS DEMONSTRATED GLOBAL LEFT VENTRICULAR HYPOKINESIS AND SOME WERE MANAGED WITH UPTITRATION OF GUIDELINE-DIRECTED MEDICAL THERAPY. THE DEVICES REMAIN IN USE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478049 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Hospitalization| R