BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4831644 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05440
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 14, 2015
    Report Date
    April 14, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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, RIGHT VENTRICULAR (RV) LEAD PACE IMPEDANCE STEADY AT APPROXIMATELY 475 OHMS THROUGH WEEK OF (B)(6) 2014, THEN IMPEDANCE BEGAN TO VARY AND HAVE OUT OF RANGE GREATER THAN 4000 OHMS MEASUREMENTS. ALERTS FOR OUT OF RANGE SUBTHRESHOLD LEAD IMPEDANCE ON (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE ATRIAL LEAD COULD NOT BE EXPLANTED, AND WAS CAPPED, ABANDONED AND REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE REVISION PROCEDURE THE ATRIAL LEAD EXHIBITED UNSTABLE IMPEDANCE. 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
    374163 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R