BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1061009 · Received June 12, 2008

    Report

    Report Number
    9610579-2008-00022
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ELA MEDICAL
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    2008. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. UPON RECEPTION, THE RETURNED DEVICE COULD NOT BE INTERROGATED WITH THE STANDARD PROGRAMMER; IN ADDITION, NO PACING PULSES WERE PRESENT. THE DEVICE WAS OPENED TO HAVE DIRECT ACCESS TO INTERNAL COMPONENTS. IN-DEPTH INVESTIGATION REVEALED THAT THERE WAS A SHORT CIRCUIT DUE TO METAL MIGRATION ON THE COFIRMED SUBSTRATE. AFTER MORE THAN FOUR YEARS OF SURVEILLANCE, THE MALFUNCTION RATE RELATED TO METAL MIGRATION OBSERVED ON SYMPHONY/RHAPSODY PACEMAKERS NOT ALREADY SUBJECTED TO AN ADVISORY IS LESS THAN 0.03 % CUMULATIVE. BECAUSE RECENTLY-PUBLISHED DATA INDICATE THAT THE AVERAGE MALFUNCTION RATE FOR ALL PACEMAKERS IS APPROXIMATELY 0.15 % PER YEAR, NO ADVISORY NOTIFICATION IS INDICATED.

    Description of Event or Problem · 1

    DURING ROUTINE FOLLOW UP, THE INTERROGATION OF THE PACEMAKER INVOLVED IN THIS MDR REPORT COULD NOT BE COMPLETED. IN ADDITION, NO PACING PULSES WERE OBSERVED. THEREFORE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY DXY - IMPLANTABLE CARDIAC PACEMAKER DXY ELA MEDICAL 2550 S040723

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention