BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 4832958 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-07321
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 9, 2015
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO, AND THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO, AND THE OUTER INSULATION OF THE LEAD WAS COSMETICALLY IMPACTED AT THE FIRST RIB/CLAVICLE SITE WHILE IN VIVO. THE INNER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION, AND THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. ANALYST COMMENTED, FRACTURE WAS CONFIRMED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, VARYING IMPEDANCE, HIGH SHORT INTERVAL COUNTS (SIC) DUE TO SUB-CLAVIAN CRUSH, AND FRACTURE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE, HIGH, VARYING IMPEDANCE AND FRACTURE. THE RV AND ATRIAL LEAD WERE 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
    380681 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 559453

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| R (B)(4) ICD, 694765 LEAD