BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4832631 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07471
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    February 10, 2015
    Report Date
    April 1, 2015
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYSIS OF THE DEVICE MEMORY INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED AND THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS DECREASING. IT WAS NOTED RIGHT VENTRICULAR CAPTURE MANAGEMENT TREND DATA SHOWED MAXIMUM THRESHOLD MEASUREMENT OF 1.75V UP TO GREATER THAN 2.5V FROM (B)(6) 2014 AND THE RV PACE IMPEDANCE TREND SHOWED STEADY DECREASE FROM AN AVERAGE OF 713 OHMS IN (B)(6) 2014 DOWN TO 402 OHMS IN (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW IMPEDANCE AND HIGH THRESHOLD MEASUREMENTS. THE RV LEAD WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373799 CAPSUREFIX DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 4068

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R