BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 4160561 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11853
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED PACING CAPTURE THRESHOLD IN THE RV (RIGHT VENTRICLE) WAS ELEVATED. VENTRICULAR CAPTURE MANAGEMENT (VCM) TRENDS SHOW AVERAGE THRESHOLD HIGH AT 2.5 THROUGHOUT THE RECORD UNTIL VCM PROGRAMMED OFF THE WEEK OF (B)(6) 2014-. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV PACING LEAD WAS BEYOND THE EXPECTED LOWER RANGE. VENTRICULAR LEAD IMPEDANCE GRADUALLY DECREASED THROUGHOUT THE RECORD TO A LIFETIME MINIMUM OF 282 OHMS BY THE END OF (B)(6) 2014.

    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: ADDRL1, IPG IMPLANTED: (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS AND DECREASED IMPEDANCE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD HAD DECREASED SENSING AND INCREASED THRESHOLD. BOTH LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641589 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 4068, LEAD