BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA¿ AV2

    MDR report key: 21707138 · Received March 27, 2025

    Report

    Report Number
    9612164-2025-01555
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 10, 2025
    Report Date
    March 27, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 UNUSUAL SHAPE OF THE HEART MADE IT DIFFICULT TO PLACE THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DELIVERY CATHETER (DS) WITH PROLONGED MANIPULATION CAUSING THE CURVE OF THE DELIVERY CATHETER TO BEND AND CHANGE SHAPE MAKING PLACEMENT EVEN MORE CHALLENGING. THE EASE OF THE DS CHANGING SHAPE MADE IT UNSUITABLE FOR USE. THE LEADLESS IPG DS 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
    1603957 MICRA¿ AV2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2AVR1-DELSYS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown