BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2862193 · Received December 7, 2012

    Report

    Report Number
    2649622-2012-17492
    Event Type
    Death
    Date Received
    December 7, 2012
    Date of Event
    July 7, 2011
    Report Date
    November 16, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 DIED. APPROXIMATELY FOUR WEEKS PRIOR TO DEATH, THE PATIENT HAD A DUAL CHAMBER PACEMAKER (PM) SYSTEM IMPLANTED; THE ATRIAL LEAD IS A COMPETITIVE PRODUCT. ON POST-OPERATIVE (POST-OP) DAY SIX THE PATIENT WAS READMITTED TO HOSPITAL WITH CHEST PAIN AND SHORTNESS OF BREATH (SOB); A "HIGH" VENTRICULAR THRESHOLD AND DECREASE IN VENTRICULAR LEAD IMPEDANCE WERE NOTED. AFTER AN ADDITIONAL ELEVEN DAYS, THE PATIENT WAS READMITTED WITH SOB AND "CHEST DISCOMFORT," AND FOUND TO BE IN ATRIAL FIBRILLATION (AF) "WITH CARDIAC FAILURE". THE PATIENT WAS ALSO "FOUND TO HAVE RAISED INFLAMMATORY MARKERS". ON POST-OP DAY (B)(6), THE PATIENT "DEVELOPED A CARDIAC TAMPONADE" AND A DRAIN WAS IMPLANTED. THE PATIENT DIED LATER THAT DAY. IT WAS CONCLUDED BY THE HOSPITAL THAT "THE LEAD" PERFORATED THE HEART MUSCLE. IT IS UNKNOWN WHICH OF THE LEADS PERFORATED NOR WHEN THE "PERICARDIAL EFFUSION" COMMENCED. A PLEURAL EFFUSION WAS ALSO NOTED. THE DISPOSITION OF THE VENTRICULAR LEAD IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Death| H| L| R (B)(4) (COMPETITIVE) IMPLANTABLE PACING LEAD