BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860204 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05541
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS OBSTRUCTED. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED DAMAGE AT IMPLANT. THE GUIDEWIRE INSERTION TEST RESULT WAS FAILED. PERFORMED DESTRUCTIVE ANALYSIS AND FOUND DRIED BLOOD OBSTRUCTION IN DISTAL CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE PHYSICIAN COULD NOT INSERT A GUIDE WIRE COMPLETELY INTO THE LEAD. THE LEAD WAS REMOVED 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
    338785 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1