BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 4161021 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11680
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 14, 2014
    Report Date
    July 24, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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 EVENT SUMMARY: A PARTIAL LEAD WAS RETURNED IN SEGMENTS. ANALYSIS REVEALED THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO AND THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. CONCOMITANT MEDICAL PRODUCTS: P1501DR IPG (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER WITH NO INFORMATION AFTER BEING EXPLANTED AND REPLACED. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. FOLLOW-UP REVEALED THAT THE NEED FOR THE LEAD EXTRACTION WAS DUE TO THE PATIENT HAVING A LEFT SUBCLAVIAN, AXILLARY VENOUS OCCLUSION NECESSITATING NEED FOR THE EXTRACTION OF LEADS TO GAIN ACCESS FOR THE PURPOSE OF IMPLANTATION/UPGRADE TO A DUAL CHAMBER PACEMAKER/DEFIBRILLATOR SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642407 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR Hospitalization| R 5568-45 LEAD 2005