BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2953406 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-01062
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED FROM BEING KINKED/BUCKLED, WAS PULLED/STRETCHED/OVERSTRESSED, HAD BLOOD (NOT OBSTRUCTED) AND WAS CUT/FRACTURED. THE DISTAL CONDUCTOR WAS DISTORTED FROM BEING PULLED/STRETCHED/OVERSTRESS, WAS KINKED/BUCKLED AND HAD BLOOD (NOT OBSTRUCTED). THE OUTER INSULATION HAD COSMETIC DEPRESSION, COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS MELTED. THE INNER INSULATION WAS BREACHED FROM BEING TORN AND THERE WAS APPARENT EXPLANT DAMAGE. CONCOMITANT PRODUCT: 6935, IMPLANTABLE DEFIBRILLATION LEAD, (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD DISLODGED. THE RA AND RV LEADS WERE BOTH 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
    57679 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407645

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR