BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICRA

    MDR report key: 10990929 · Received December 11, 2020

    Report

    Report Number
    9612164-2020-04874
    Event Type
    Death
    Date Received
    December 11, 2020
    Date of Event
    November 20, 2020
    Report Date
    November 6, 2025
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00643169928725
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    MICRA: MODEL #: MC1VR01/ EXPIRATION DATE: 2021-11-14 / SERIAL#: (B)(4). UDI #: (B)(4). NO DEV RTN TO MFR? NO. MFG DATE: 2020-08-10 LABELED FOR SINGLE USE? YES. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PATIENT EXPERIENCED A SUSPECTED PERFORATION AND PERICARDIAL TAMPONADE. THE OPE RATION WAS TERMINATED AND THE PATIENT WAS RESCUED IMMEDIATELY. BOTH THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) AND THE DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AND THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1454794 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01 00643169928725

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Female Death