BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1034138 · Received April 23, 2008

    Report

    Report Number
    2182863-2008-00024
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 23, 2008
    Manufacturer
    ELA MEDICAL, S.A.S.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DATE ANALYSIS/INVESTIGATION COMPLETED: 04/01/08. DEVICES SOLD AND LABELLED AS STERILE ARE MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. MANUFACTURING DATA FOR THE PACEMAKER IN OBJECT: MANUFACTURING DATE: JULY 11, 2006. USE BEFORE DATE: FEB 11, 2008. STERILIZATION LOT NUMBER: M060728. 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. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    AFTER 18+ MONTHS 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. 2550 M060728

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R