BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE+

    MDR report key: 2532448 · Received April 12, 2012

    Report

    Report Number
    2649622-2012-04753
    Event Type
    Malfunction
    Date Received
    April 12, 2012
    Date of Event
    November 8, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P830061/S24
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WARNING WAS TRIGGERED DUE TO THE POLARITY OF THE RIGHT ATRIAL (RA) LEAD SWITCHING FROM BIPOLAR TO UNIPOLAR. THE UNIPOLAR IMPEDANCE TREND WAS STABLE IN THE RANGE OF 240-280 OHMS. ON MANUAL IMPEDANCE TEST, THE BIPOLAR IMPEDANCE WAS MEASURED TO BE 145 OHMS. AFTER CONSULTING WITH THE PHYSICIAN, IT WAS DECIDED THAT THE PATIENT WILL BE FOLLOWED CLOSELY TO DETERMINE THE PERFORMANCE STABILITY OF THE RA LEAD. THE 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
    1 EXCELLENCE+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IMD49JB

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB