BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1073683 · Received July 10, 2008

    Report

    Report Number
    9610579-2008-00024
    Event Type
    Malfunction
    Date Received
    July 10, 2008
    Date of Event
    May 30, 2008
    Report Date
    July 4, 2008
    Manufacturer
    ELA MEDICAL
    Product Code
    DXY
    Removal / Correction Number
    Z-0266-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE WAS LISTED IN THE FIELD SAFETY NOTICE WHICH WAS ISSUED IN OCTOBER 2005 RELATED TO METAL MIGRATION ON SYMPHONY/RHAPSODY DEVICES (GROUP NO.1 OF THE EXPOSED POPULATION). THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING ROUTINE FOLLOW UP, THE PACEMAKER INVOLVED IN THIS MDR REPORT DID NOT PACE OR REACT UPON MAGNET APPLICATION. THEREFORE IT WAS EXPLANTED. THE PHYSICIAN WAS AWARE THAT THIS DEVICE WAS LISTED IN GROUP NO. 1 OF THE FIELD SAFETY NOTICE ISSUED IN 2005 RELATED TO METAL MIGRATION ON SYMPHONY / RHAPSODY. THIS FIELD ACTION WAS RECORDED UNDER RECALL IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY DXY - IMPLANTABLE CARDIAC PACEMAKER DXY ELA MEDICAL 2550 S030804

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention