BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 4160840 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02789
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 14, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS HIGH IMPEDANCE AND CONFIRMED FRACTURE ON THE LEAD. THE LEAD WAS 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
    640776 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R