BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA AV

    MDR report key: 24995267 · Received April 27, 2026

    Report

    Report Number
    9612164-2026-02167
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 21, 2026
    Report Date
    April 27, 2026
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00763000078669
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 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 DURING THE IMPLANT PROCEDURE THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DELIVERY SYSTEM (DS) EXHIBITED A WEAKNESS IN THE CURVE SHAPE WHEN "TORQUING" THE DISTAL PART OF THE DS IN A SMALL VENTRICULAR CAVITY ANATOMY. SEVERAL ATTEMPTS WERE ATTEMPTED TO PASS THROUGH THE TRICUSPID VALVE AND POSITION ON THE VENTRICULAR SEPTUM, AND WITH GENTLY TWISTING THE DS WAS DEFORMED, MAKING IT IMPOSSIBLE TO CONTINUE THE IMPLANTATION. THE LEADLESS IPG WAS ATTEMPTED NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302360 MICRA AV LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1AVR1 00763000078669

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown