BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811709 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16630
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. NO ANOMALIES WERE FOUND. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS. THE PROXIMAL CONDUCTOR WAS MELTED. THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION WAS MELTED. THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING AND A COSMETIC DEPRESSION ON THE OUTER INSULATION. THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS STRETCHED. VISUAL ANALYSIS REVEALED THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD DEMONSTRATED AN INTERMITTENT INCREASE IN IMPEDANCE MEASUREMENTS. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4076

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R