BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA¿ AV2

    MDR report key: 22200789 · Received June 13, 2025

    Report

    Report Number
    9612164-2025-02901
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    May 26, 2025
    Report Date
    June 13, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME [MICRA] PRODUCT ID [MC2AVR1-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 THAT DURING THE IMPLANT PROCEDURE OF THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) AFTER DEPLOYMENT THE PULL-AND-HOLD TEST WAS STRONG AND THE LEADLESS IPG RETURNED TO THE TIP OF THE DELIVERY SYSTEM (DS) IN THE RIGHT ATRIUM AFTER A SEMI-ROTATION. THE TINE AND TETHER BECAME ENTANGLED WHEN THE TETHER WAS PULLED. THE TETHER WAS LOOSENED AND THE DS WAS RAISED AND LOWERED, BUT THE ENTANGLEMENT COULD NOT BE RELEASED AND THE DS TIP RETURNED FROM THE ELECTRODE SIDE OF THE LEADLESS IPG. THE CATHETER WAS MOVED BACK AND FORTH IN THE RIGHT ATRIUM AND AN ATTEMPT WAS MADE TO REMOVE IT WITHOUT SUCCESS. THE LEADLESS IPG WAS SUCCESSFULLY REMOVED WITH A SNARE THROUGH THE JUGULAR VEIN. THE LEADLESS IPG DS WAS ATTEMPTED NOT USED, REMOVED 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
    353903 MICRA¿ AV2 LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC2AVR1

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H