BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYMPHONY

    MDR report key: 679964 · Received February 24, 2006

    Report

    Report Number
    2182863-2006-00010
    Event Type
    Other
    Date Received
    February 24, 2006
    Date of Event
    January 25, 2006
    Report Date
    February 24, 2006
    Manufacturer
    ELA MEDICAL S.A.S.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ONE DAY POST-IMPLANT DURING THE INTERROGATION. IT WAS REPORTED THAT THE PARAMETERS SEEMED ALTERED IN REGARDS TO THE DISPLAYED R RATE VALUE, THRESHOLD TESTS, P & R MEASUREMENTS AND AIDA OPERATIONS. HOWEVER, THE DEVICE APPEARED TO BE OPERATING FORMALY, SENSING AND PACING THRESHOLDS WERE FOUND NORMAL. ELA MEDICAL, INC. RECOMMENDED PUTTING THE DEVICE INTO STANDBY MODE BY USING CUSTOM ENGINEERING SOFTWARE IN ORDER TO RESTORE NORMAL BEHAVIOR. THIS RESET WAS SUCCESSFULLY COMPLETED IN FEBRUARY 2005, THIS RESTORED NORMAL BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL S.A.S. 2550 S060110

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other