BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY DR

    MDR report key: 1523001 · Received October 19, 2009

    Report

    Report Number
    1000165971-2009-00028
    Event Type
    Injury
    Date Received
    October 19, 2009
    Date of Event
    October 7, 2009
    Report Date
    October 19, 2009
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OCTOBER 19, 2009. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE DEVICE INVOLVED IN THIS MDR REPORT WAS IMPLANTED 2009 WITH AN EPICARDIAL LEAD. ONE MONTH LATER, LOSS OF OUTPUT AND/OR CAPTURE AND HIGH LEAD IMPEDANCE WERE OBSERVED. THEREFORE THE LEAD WAS CAPPED AND THE PACEMAKER WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY DR DXY - IMPLANTABLE CARDIAC PACEMAKER DXY SORIN BIOMEDICA CRM S.R.L. REPLY DR 2380

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R