BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1339865 · Received March 11, 2009

    Report

    Report Number
    2182863-2009-00013
    Event Type
    Malfunction
    Date Received
    March 11, 2009
    Date of Event
    February 8, 2009
    Report Date
    March 11, 2009
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS ON THIS DEVICE IS PENDING.

    Additional Manufacturer Narrative · 1

    THE ANALYSIS ON THIS DEVICE IS PENDING. OCTOBER 19, 2009

    Description of Event or Problem · 1

    THIS PACEMAKER WAS NOT IMPLANTED BECAUSE OF INTERMITTENT PACING.

    Description of Event or Problem · 1

    THIS PACEMAKER WAS NOT IMPLANTED BECAUSE OF INTERMITTENT PACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL, S.A.S. 2550

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other