BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2810820 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16312
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 21, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED BUCKLED, THE INNER TUBING WAS KINKED BUCKLED, THE OUTER INSULATION HAD A WHITE SUBSTANCE AND COSMETIC DEPRESSION, THE LEAD WAS STRETCHED AND VISUAL ANALYSIS SHOWED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHANGE OUT PROCEDURE THE LEAD SHOWED HIGH IMPEDANCE MEASUREMENTS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 83 YR Hospitalization| R CL560U IMPLANTABLE PACEMAKER/CARDIO/DEFIB