BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4162481 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12733
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 ON THE ATRIAL PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED ATRIAL PACING CAPTURE THRESHOLD WAS ELEVATED. ANALYST COMMENTED, ATRIAL PACE IMPEDANCE STEADY AT APPROXIMATELY 700 OHMS THROUGH (B)(6) 2014, RISES OUT OF RANGE, GREATER THAN 4000 OHMS STARTING (B)(6) 2014. VARIABLE THRESHOLDS FOR LIFE OF ATRIAL CAPTURE MANAGEMENT TREND. BEGAN TORISE IN (B)(6) 2013, STAYING HIGH (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).

    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 IMPLANTABLE TACHY LEAD (ITL) EXHIBITED HIGH THRESHOLD, HIGH IMPEDANCE WITH A POSSIBLE FRACTURE NOTED. DIAGNOSTIC, TESTING, TROUBLESHOOTING WAS PERFORMED. THE ITL REMAINS IN USE, HOWEVER THERE IS SCHEDULED EXPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640031 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R