BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA¿ AV2

    MDR report key: 23648816 · Received November 25, 2025

    Report

    Report Number
    9612164-2025-05835
    Event Type
    Injury
    Date Received
    November 25, 2025
    Date of Event
    October 21, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE AGE CHARACTERISTICS IS 70 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: LEADLESS PACEMAKER TINE FRACTURE AND DISLOCATION: TWO CASE REPORTS. BMC CARDIOVASCULAR DISORDERS. 2025. 25: 756. DOI: 10.1186/S12872-025-05233-2. 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 LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) TINE FRACTURE AND DISLOCATION. THE AUTHORS DESCRIBED TWO PATIENTS IMPLANTED WITH LEADLESS IPGS AND THEIR IPGS MIGRATED AND EXHIBITED TINE FRACTURE. THE FIRST PATIENT PRESENTED ONE MONTH POST IMPLANT AND ELECTROCARDIOGRAM (ECG) SHOWED LOSS OF CAPTURE. IMAGING DEMONSTRATED THE DEVICE EMBOLIZED INTO THE PULMONARY ARTERY AND A FIXATION TINE EMBEDDED IN THE RIGHT VENTRICULAR SEPTUM. DEVICE RETRIEVAL WAS DECLINED, AND THEY IMPLANTED A NEW LEADLESS DEVICE. THE OTHER PATIENT EXPERIENCED CHEST DISCOMFORT APPROXIMATELY ONE MONTH POST IMPLANT. A FOLLOW-UP IPG INTERROGATION REVEALED BATTERY LIFE LESS THAN TWO MONTHS AND A HIGH THRESHOLD. TRANSTHORACIC ECHOCARDIOGRAPHY AND CHEST X-RAY CONFIRMED DISLODGEMENT OF THE LEADLESS IPG. THE DEVICE WAS SNARED AND RETRIEVED. AN ATTEMPT WAS MADE TO IMPLANT ANOTHER LEADLESS IPG, BUT THE PARAMETERS WERE NOT IDEAL IN ANY LOCATION WITH HIGH THRESHOLDS. THE IMPLANT OF THE LEADLESS IPG WAS ABANDONED AND A TRANSVENOUS SYSTEM WAS IMPLANTED INSTEAD. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1948759 MICRA¿ AV2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2AVR1

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Unknown Required Intervention| H