BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCELLENCE+

    MDR report key: 4163355 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12376
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    May 1, 2013
    Report Date
    July 10, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. CONCOMITANT MEDICAL PRODUCTS: IMD49JB53 LEAD, IMPLANTED (B)(6) 2001. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD SHOWED A CHANGE IN PACING CONFIGURATION DUE TO HIGH BIPOLAR IMPEDANCE ALONG WITH DOWNWARD TRENDING UNIPOLAR IMPEDANCE. THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644125 EXCELLENCE+ DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI IMD49B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R ADDR01 IPG