BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1060266 · Received June 10, 2008

    Report

    Report Number
    2182863-2008-00032
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 12, 2008
    Report Date
    June 10, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE RECORDS SHOWED THAT THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. PLEASE SEE THE ATTACHED ANALYSIS FOR COMPLETE DETAILS.

    Description of Event or Problem · 1

    AFTER 29 MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF AN INFECTION. NOTE: THE LEAD THAT WAS ATTACHED TO THIS PACEMAKER WAS ALSO REMOVED AND REPORTED ON AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL, S.A.S. 2550 S050927

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R