BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2791560 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14841
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 AND ANALYZED. THE DISTAL CONDUCTOR WAS FRACTURED. THE PROXIMAL CONDUCTOR WAS DISTORTED. THE INNER INSULATION WAS KINKED/BUCKLED. THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION HAD A WHITE SUBSTANCE AND HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THE LEAD WAS STRETCHED. VISUAL ANALYSIS NOTED DIATAL CONTINUITY FAILED DUE TO CONDUCTOR FRACTURED--DISTAL CONDUCTOR FRACTURED. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS FRACTURED. THE PROXIMAL CONDUCTOR WAS DISTORTED. THE INNER INSULATION WAS KINKED/BUCKLED. THE INNER TUBING WAS KINKED/BUCKLED. THE OUTER INSULATION HAD COSMETIC CUT, HAD A WHITE SUBSTANCE, AND HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. THERE WAS TISSUE ON THE HELIX. THE LEAD WAS STRETCHED. VISUAL ANALYSIS NOTED DISTAL CONTINUITY FAILED DUE TO CONDUCTOR FRACTURED--DISTAL CONDUCTOR FRACTURED.

    Description of Event or Problem · 1

    THE RIGHT VENTRICULAR (RV) AND ATRIAL (RA) LEADS WERE RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. INFORMATION RECEIVED FROM THE CLINIC DISCLOSED THAT THE RA LEAD WAS FRACTURED AND WAS KINKING AT THE VENOUS INSERTION SITE. THE CLINIC STATED NO PERFORMANCE ISSUE FOR THE RV LEAD. THE RV LEAD WAS EXPLANTED IN ASSOCIATION TO ISSUES RELATED TO THE RA LEAD. 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. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR