BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY / RHAPSODY

    MDR report key: 853620 · Received May 22, 2007

    Report

    Report Number
    9610579-2007-00026
    Event Type
    Injury
    Date Received
    May 22, 2007
    Date of Event
    April 13, 2007
    Report Date
    September 16, 2007
    Manufacturer
    ELA MEDICAL S.A.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON MAY 16, 2007, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE OF THE UNITED STATES. THE ANALYSIS OF THE DEVICE IS PENDING.

    Description of Event or Problem · 1

    AFTER 28 MONTHS OF IMPLANTATION, THE DEVICE INVOLVED IN THIS MDR REPORT WAS EXPLANTED BECAUSE ABSENCE OF OUTPUT AND HIGH IMPEDANCE WERE OBSERVED IN BOTH CHANNELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY / RHAPSODY IMPLANTABLE CARDIAC PACEMAKER DXY ELA MEDICAL S.A. 2530 S040915

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Hospitalization| R