BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 3860044 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-05606
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 6, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. THE PROXIMAL CONDUCTOR OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO PULLING/STRETCHING/OVERSTRESS. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE OUTER INSULATION OF THE LEAD BECAME EXTRINSICALLY DISTORTED DUE TO KINKING/BUCKLING. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 6947, LEAD, IMPLANTED: (B)(6) 2012; 4196, LEAD, IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE RIGHT ATRIAL (RA) LEAD AND THE LEFT VENTRICULAR (LV) LEAD DISLODGED. THE RIGHT ATRIAL (RA) LEAD WAS REPOSITIONED AND AN ATTEMPT TO REPLACE THE LEFT VENTRICULAR (LV) LEAD WAS UNSUCCESSFUL DUE TO PATIENT ANATOMY. CONSEQUENTLY, THE SAME LEFT VENTRICULAR (LV) LEAD WAS USED. ALSO REPORTED WAS THAT THE RIGHT ATRIAL (RA) LEAD DEMONSTRATED LOW P WAVES AND THE RIGHT VENTRICULAR (RV) LEAD DEMONSTRATED A LACK OF R WAVES. ADDITIONALLY, THE PATIENT DEVELOPED AN INFECTION AND THE SYSTEM WAS REMOVED AND REPLACED EXCEPT THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE REPLACED DUE TO PATIENT ANATOMY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340359 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R