BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 735796 · Received July 15, 2005

    Report

    Report Number
    2182863-2005-00040
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    December 1, 2004
    Report Date
    July 15, 2005
    Manufacturer
    ELA MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JULY 15, 2005. CODE 086 (OTHER): REVIEW OF THE PRODUCTION HISTORY AND STERILIZATION RECORDS. CODE 100 (OTHER): REVIEW OF THE PRODUCTION HISTORY AND STERILIZATION RECORDS SHOWED THAT THIS DEVICE WAS IN SPECIFICATION ACCORDING TO THE STANDARD OPERATING PROCEDURES. DEVICES SOLD AND LABELLED AS STERILE ARE MFG, STERILIZED AND RELEASED TO APPLICABLE STANDARD OPERATING PROCEDURES. MOREOVER, IT SHOULD BE NOTED THAT INFECTION IS A WELL-KNOWN COMPLICATION OF CARDIAC PACING/DEFIBRILLATION SYSTEMS, AND THIS HAS ALREADY BEEN DESCRIBED IN THE LITERATURE.

    Description of Event or Problem · 1

    AFTER 5+ MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF AN INFECTION. NOTE: THIS WAS NOT REPORTED TO ELA MEDICAL, INC. UNTIL JUNE 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL 2250 S040419

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R