BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6005816 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-11526
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    August 23, 2016
    Report Date
    August 23, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PATIENT APPEARED TO BE IN ATRIAL FIBRILLATION AND EXPERIENCED SYNCOPE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDER SENSING, AND P-WAVES WERE NOTED TO BE SMALL. THE LEAD 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
    657508 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Life Threatening A2DR01 IPG, 5076-52 LEAD