BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z NOVUS

    MDR report key: 3191389 · Received June 26, 2013

    Report

    Report Number
    2649622-2013-07921
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    April 27, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. RIGHT VENTRICULAR (RV) THRESHOLD STABLE AROUND 0.9V MAX, AND 0.65V AVERAGE, AVERAGE MAX AMPLITUDE SETTING: 1.5V. IMPEDANCE TREND STABLE AND WITHIN RANGE. 120 SHORT INTERVAL COUNTS (SIC) SINCE (B)(6)-2009 AND NO LEAD WARNING.

    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 PRODUCTS: ADDRS1 IMPLANTABLE PULSE GENERATOR, IMPLANTED: (B)(6) 2003; 5554 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    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 HAS OCCASIONALLY FELT LASSITUDE OVER THE PREVIOUS TWO MONTHS. ON ELECTROCARDIOGRAM, THE RIGHT VENTRICULAR LEAD DID NOT HAVE CAPTURE. THE THRESHOLD WAS ALSO NOTED TO HAVE INCREASED. THE DEVICE WAS REPROGRAMMED AND THE LEAD REMAINS 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
    291443 CAPSURE Z NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5054-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Required Intervention