BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3991801 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-07945
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    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 US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO CRACKS WERE SEEN APPROXIMATELY 5 MILLIMETERS APART AT THE PROXIMAL PORTION OF THE PACING LEAD BEFORE THE THICKER TUBING THAT CONNECTS TO THE PIN CONNECTOR. IT WAS NOTED THAT THE CONDUCTORS WERE VISIBLE WITH MANIPULATION AND THE AREA BETWEEN THE CRACKS SUGGESTED INSULATION DEGRADATION. THE PACING LEAD WAS CAPPED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472442 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4092-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Hospitalization| R