BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1920608 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12314
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    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. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LOSS OF CAPTURE, INTERMITTENT CAPTURE, FAILURE TO SENSE AND EXTRACARDIAC STIMULATION WITH THE ATRIAL LEAD. IT WAS ALSO NOTED THAT THE "ROOT CAUSE" OF THE EVENT WAS "PATIENT PHYSIOLOGY". THE LEAD WAS FIRST PROGRAMMED OFF (BY PROGRAMMING TO A VENTRICULAR MODE, VVI) AND LATER ABANDONED/CAPPED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4067 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R