BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952055 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00360
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED (IN-VIVO) FROM BEING FLEXED. IT WAS ALSO NOTED THAT THE DISTAL END LOW VOLTAGE ELECTRODE WAS COVERED IN BLOOD, THE DISTAL CONDUCTOR WAS DISTORTED FROM OVER-ROTATION, AND THE PROXIMAL CONDUCTOR HAD BLOOD (NOT OBSTRUCTED). ALSO, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, WAS BREACHED/CUT, AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THE INNER INSULATION WAS DISTORTED FROM BEING KINKED/BUCKLED. CONCOMITANT PRODUCT: 4195 IMPLANTABLE PACING LEAD 2009 (B)(6), 6947 IMPLANTABLE DEFIBRILLATION LEAD 2009 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD A SUSPECTED FRACTURE, NO CAPTURE, IMPEDANCE ELEVATED FROM APPROXIMATELY 500 OHMS TO 2900 OHMS AND OVERSENSING. THE RA LEAD WAS EXPLANTED 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
    57766 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR