BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 4162472 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12743
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 14, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYST COMMENTED, ATRIAL LEAD UNIPOLAR IMPEDANCE RISES FROM AN APPROXIMATE BASELINE OF 700 OHMS TO GREATER THAN 3000 OHMS THE WEEK ENDING 2014 (B)(6).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: A5DR01, IPG, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ATRIAL LEAD ALERT IN UNIPOLAR CONFIGURATION WAS TRIGGERED DUE TO THE LEAD POLARITY SWITCH TO UNIPOLAR. THE ATRIAL LEAD EXHIBITED HIGH IMPEDANCE, HIGH THRESHOLD AND AS A RESULT ADJUSTMENTS TO OUTPUT SETTINGS WERE MADE. SUBSEQUENTLY, THE ATRIAL LEAD EXHIBITED NO CAPTURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED TO VVI MODE. THE ATRIAL LEAD REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640029 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Hospitalization| R 5076-52 LEAD