BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 6161718 · Received December 9, 2016

    Report

    Report Number
    2649622-2016-14778
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 16, 2016
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 TREND ON THE RIGHT VENTRICULAR (RV) PACING LEAD WAS RISING, AND PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED. ANALYST COMMENTED, BETWEEN 25-JULY-2015 AND 10-SEPTEMBER-2016, RV CAPTURE THRESHOLD MEASURED GREATER THAN 2.5 VOLTS. BETWEEN (B)(6) 2015 AND (B)(6) 2016, RV PACING IMPEDANCE ROSE FROM 700 OHMS TO 1411 OHMS.

    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 DURING USE THE RIGHT VENTRICULAR (RV) PACE/SENSE LEAD EXHIBITED HIGH AND PERSISTENT IMPEDANCE INCREASE AND RISING THRESHOLDS. THE RV LEAD REMAINS IN USE AND PATIENT TO BE MONITORED DURING FOLLOW UP VISITS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808560 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 507645 LEAD, ADDR01 IPG