BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SP

    MDR report key: 2791730 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15465
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S10
    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. 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 THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE IN BIPOLAR CONFIGURATION. IT WAS ALSO NOTED THE LEAD TREND DEMONSTRATED INFINITE BIPOLAR PACING LEAD IMPEDANCE. THE SENSING WAS REPROGRAMMED TO UNIPOLAR CONFIGURATION AND THE ISSUE RESOLVED. IN ADDITION, IT WAS NOTED THE ATRIAL LEAD TREND DEMONSTRATED INFINITE BIPOLAR PACING IMPEDANCE AND THE UNIPOLAR PACING IMPEDANCE SHOWED A NORMAL TREND. THE LEADS REMAIN 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
    1 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4523

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention C2TR01 IMPLANTABLE PULSE GENERATOR