BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 611393 · Received June 7, 2005

    Report

    Report Number
    9610579-2005-00033
    Event Type
    Injury
    Date Received
    June 7, 2005
    Date of Event
    May 11, 2005
    Report Date
    June 7, 2005
    Manufacturer
    ELA MEDICAL
    Product Code
    DYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER ONE DAY OF IMPLANTATION, THE DEVICE INVOLVED IN THIS MDR REPORT WAS EXPLANTED AND RETURNED BECAUSE THE ATRIAL PACING PULSE LED TO THE VENTRICULAR DEPOLARISATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY IMPLANTABLE CARDIAC PACEMAKER DYX ELA MEDICAL 2550 S050415

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R