BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 6161493 · Received December 9, 2016

    Report

    Report Number
    9612164-2016-01257
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    September 30, 2016
    Report Date
    September 30, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    PNJ
    UDI-DI
    00643169529748
    PMA / PMN Number
    P150033
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 PHYSICIAN HAD DIFFICULTY PLACING THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) ON THE SEPTAL WALL DUE TO EXISTING ATRIAL AND VENTRICULAR LEADS. THE IPG WAS REPOSITIONED THREE TIMES DUE TO UNACCEPTABLE IMPEDANCE AND THRESHOLD VALUES. AFTER THE THIRD PLACEMENT THE IPG WAS REMOVED FROM THE PATIENT AND A CLOT WAS NOTED ON THE DISTAL END OF THE IPG. THE CLOT WAS REMOVED AND THE IPG PLACED WITH GOOD PARAMETERS. THE PATIENT WAS TRANSFERRED TO RECOVERY AND SHORTLY THEREAFTER THE PATIENT¿S HEART RATE WAS 30 BPM (BEATS PER MINUTE). THE DEVICE THRESHOLD HAD INCREASED. THE PHYSICIAN TURNED THE LEADLESS IPG OFF AND TURNED THE PREVIOUS IPG BACK ON. THE FOLLOWING MORNING THE THRESHOLD WAS IMPROVED AND THE LEADLESS IPG TURNED BACK ON AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809310 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01US 00643169529748

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention