BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1477962 · Received September 21, 2009

    Report

    Report Number
    2182863-2009-00065
    Event Type
    Injury
    Date Received
    September 21, 2009
    Date of Event
    August 21, 2009
    Report Date
    September 21, 2009
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEPTEMBER 21, 2009. SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES.

    Description of Event or Problem · 1

    AFTER ALMOST 3 YEARS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL, S.A.S. 2250 M060728

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Hospitalization| R