BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 3153530 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06077
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 CAPTURE MANAGEMENT HAD SEEN HIGH THRESHOLDS ON THE RIGHT VENTRICULAR (RV) LEAD, HOWEVER, THRESHOLDS MEASURED IN CLINIC APPEARED TO BE WITHIN NORMAL RANGE. THE LEAD IMPEDANCE HAS DECREASED OVER TIME. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257769 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4023

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR SESR01 IMPLANTABLE PULSE GENERATOR (IPG)