BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4313031 · Received December 10, 2014

    Report

    Report Number
    2649622-2014-14151
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    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. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. ABRUPT INCREASE IN RV IMPEDANCE FROM 600-700 TO 1200-400 OHMS WEEK ENDING (B)(6) 2013. ALERT FOR OUT OF RANGE SUBTHRESHOLD LEAD IMPEDANCE ALERT ON (B)(6) 2013. OBSERVED HIGH IMPEDANCE ON RV LEAD; OTHER MEASUREMENTS USING RV TIP ALSO OUT OF RANGE; NO NSTS. SICS ARE WITHIN NORMAL LIMITS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, LEAD WAS OPENED AND THE DOCTOR WAS NOT HAPPY WITH THE INSULATION OF THE LEAD. ANOTHER LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802875 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR