BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4161147 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11622
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 22, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE RIGHT VENTRICULAR (RV) LEAD WAS OVERSENSING. THE LEAD PROGRAMMING WAS CHANGED AND THE RV LEAD REMAINS IN USE. THE PATIENT WAS A PARTICIPANT IN THE (B)(6) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637491 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention