BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955511 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01471
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    November 28, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. CONCOMITANT THERAPY: P1501DR IMPLANTABLE PULSE GENERATOR: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE OUTER INSULATION WAS BREACHED AT THE FIRST RIB/CLAVICLE. IT WAS ALSO NOTED THAT THE PROXIMAL CONDUCTOR WAS FLATTENED, PULLED, STRETCHED AND OVERSTRESSED. THERE WAS BLOOD (NOT OBSTRUCTED) ON THE DISTAL AND PROXIMAL CONDUCTORS. THE DISTAL END OF THE ELECTRODE WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE HELIX WAS BENT, PULLED, STRETCHED AND OVERSTRESSED. THE OUTER INSULATION WAS BREACHED CUT, MELTED AND TORN. THE OUTER INSULATION HAD COSMETIC INSULATION DEPRESSION AND A WHITE SUBSTANCE. IT WAS VISUALLY NOTED THAT THE LEAD WAS STRETCHED. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH SEVERE EXPLANT DAMAGE, ALONG WITH OUTER INSULATION THAT WAS BREACH/DISTORTED INDICATION OF 1ST RIB/CLAVICLE RUSH HAD OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD RISING AND HIGH IMPEDANCE OVER THE PAST 18 MONTHS. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD THRESHOLDS HAVEN'T CHANGED, BUT ARE "SOMEWHAT ELEVATED." THE ATRIAL LEAD REMAINS IN USE AND WILL BE REPLACED DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD HAD RISING AND HIGH IMPEDANCE OVER THE PAST 18 MONTHS DUE TO A POSSIBLE FRACTURE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD THRESHOLDS HAVEN'T CHANGED, BUT ARE "SOMEWHAT ELEVATED". THE ATRIAL LEAD HAS BEEN EXPLANTED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57950 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 5076-52 IMPLANTABLE PACING LEAD