BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRA

    MDR report key: 7093844 · Received December 7, 2017

    Report

    Report Number
    9612164-2017-01794
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    October 4, 2017
    Report Date
    December 7, 2017
    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
    CO, 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 THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED RISING THRESHOLDS TO HIGH LEVELS AND LOSS OF CAPTURE. THE IPG WAS UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872884 MICRA LEADLESS PACEMAKER PNJ MEDTRONIC IRELAND MC1VR01US 00643169529748

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R