BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA¿ VR2

    MDR report key: 23177966 · Received September 30, 2025

    Report

    Report Number
    9612164-2025-04810
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    September 29, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME [MICRA] PRODUCT ID [MC2VR01-DELSYS] (SERIAL: (B)(6). D9: NO 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 DURING IMPLANT OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), DURING POSITIONING OF THE DELIVERY SYSTEM (DS) AND CONTRAST INJECTION THERE WAS EVIDENCE OF CONTRAST IN THE PERICARDIUM. A PERICARDIAL EFFUSION OCCURRED AND THE PATIENT EXPERIENCED CARDIAC TAMPONADE FORM PERFORATION AND PERICARDIOCENTESIS WAS PERFORMED, DRAINING TWO HUNDRED AND FIFTY MILLILITERS OF FLUID. THE PATIENT WAS INTUBATED. THE LEADLESS IPG AND DS WERE ATTEMPTED/NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773508 MICRA¿ VR2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2VR01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L| H