BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRA

    MDR report key: 23617342 · Received November 21, 2025

    Report

    Report Number
    9612164-2025-05796
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    November 19, 2025
    Report Date
    November 21, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    DYB
    UDI-DI
    00763000770730
    PMA / PMN Number
    K132030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    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 OF A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG), THE DELIVERY SYSTEM (DS) AND LEADLESS IPG EXHIBITED PLACEMENT DIFFICULTY. DURING THE REMOVAL OF THE DS, THE TWO PRESSURIZED SALINE BAGS WERE INADVERTENTLY INVERTED WHICH COMPROMISED THE FLUSH INTENDED FOR THE INTRODUCER. FOLLOWING PARTIAL RETRACTION, THE DS BECAME STUCK, EXHIBITING SIGNIFICANT RESISTANCE AND A TENDENCY TO RETRACT INWARD, RENDERING FURTHER EXTRACTION IMPOSSIBLE. BY APPLYING STEADY TRACTION TO THE DS WHILE SIMULTANEOUSLY ADVANCING THE SHEATH, THE LEADLESS IPG WAS SUCCESSFULLY RECAPTURED AND WITHDRAWN. UPON EXTERNAL EXAMINATION, THE TETHER WAS OBSERVED TO BE BRAIDED AND TIGHTLY TANGLED, HAVING FORMED A KNOT BETWEEN THE CATHETER AND THE PROXIMAL END OF THE LEADLESS IPG. 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
    2118407 MICRA INTRODUCER, CATHETER DYB MEDTRONIC IRELAND MI2355A P2F25D0022 00763000770730

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male