BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 2200523 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11011
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S33
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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. EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. NO ANOMALIES WERE FOUND. THE ANALYST NOTED THAT THERE WERE SOME SLIGHTLY HIGHER VENTRICULAR LEAD MEASUREMENTS IN OCTOBER 2010 (1400-1500 OHMS), BUT THERE WERE NOT ISSUES WITH CAPTURE MANAGEMENT OTHER THAN A FLUCTUATION THRESHOLD (0.875 TO 1.75V).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DEVICE DEPENDENT IN THE VENTRICLE. THE DEVICE WAS LOSING CAPTURE AFTER VENTRICULAR PACES AND THE CAPTURE MANAGEMENT FEATURE MAY HAVE LOWERED THE CAPTURE THRESHOLD INAPPROPRIATELY. IT WAS LATER REPORTED THAT THE DEVICE WAS EXPLANTED. THE RIGHT VENTRICULAR LEAD WAS REPORTED TO HAVE HIGH IMPEDANCE UPON ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE Z IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5034 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R