BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA¿ AV2

    MDR report key: 23451397 · Received November 3, 2025

    Report

    Report Number
    9612164-2025-05379
    Event Type
    Injury
    Date Received
    November 3, 2025
    Date of Event
    April 1, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000078645
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. F1 USER FACILITY BANNER BOSWELL MEDICAL CENTER F2 UF/IMPORTER REPORT NUMBER: (B)(4). F3 USER FACILITY NAME/ADDRESS: (B)(6) F4 CONTACT PERSON: (B)(6). F5 PHONE NUMBER: (B)(6). F6 DATE USER FACILITY BECAME AWARE OF THE EVENT: F7 TYPE OF REPORT: INITIAL F8 DATE OF THIS REPORT: SEP-2025. F9 APPROXIMATE AGE OF DEVICE: F10 EVENT PROBLEM CODES: PNJ F11 REPORT SENT TO FDA: F12 LOCATION WHERE EVENT OCCURRED: F13 REPORT SENT TO MANUFACTURER: YES, F14 MANUFACTURER NAME AND ADDRESS: MFR. NAME: MEDTRONIC ADDRESS: (B)(6). 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

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE AFTER THE IMPLANT OF AN LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WHEN THE TEMPORARY IPG WAS TURNED OFF.  THE LEADLESS IPG DID NOT PACE AND COMPRESSION WERE INITIATED. IT WAS THEN REPLACED WITH A NEW LEADLESS IPG. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886982 MICRA¿ AV2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2AVR1 00763000078645

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Other