BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6007517 · Received October 6, 2016

    Report

    Report Number
    2649622-2016-12757
    Event Type
    Injury
    Date Received
    October 6, 2016
    Date of Event
    July 25, 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
    FL, 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 WITHIN ONE MONTH OF IMPLANT, THE RIGHT VENTRICULAR LEAD THRESHOLD WAS NOTED TO BE UNSTABLE AND THE RIGHT ATRIAL LEAD WAS NOTED TO HAVE INTERMITTENT HIGH THRESHOLD. BOTH LEADS WERE EXAMINED UNDER FLUOROSCOPY AND APPEARED TO HAVE NO SLACK. THE VENTRICULAR LEAD WAS REPOSITIONED AND SLACK WAS ADDED TO THE ATRIAL LEAD. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656619 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R A2DR01 IPG, 5076-45 LEAD