BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNMPHONY

    MDR report key: 794135 · Received December 9, 2004

    Report

    Report Number
    2182863-2004-00063
    Event Type
    Other
    Date Received
    December 9, 2004
    Date of Event
    April 15, 2004
    Report Date
    December 9, 2004
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS REVIEW OF PRODUCTION HISTORY RECORDS SHOWED THAT THIS DEVICE WAS IN SPECIFICATION WHEN IT WAS RELEASED. THE PROGRAMMING FILES SHOWED THAT THE PROGRAMMING HEAD SOFTWARE WAS THE CAUSE OF THE REPORTED BEHAVIOR. THE ORGIN OF THE REPORTED BEHAVIOR WAS THE RESULT OF THE PROGRAMMING HEAD SOFTWARE. NEWER VERSIONS HAVE BEEN IMPROVED TO PREVENT A REOCCURRENCE OF SUCH AN EVENT. REVIEW OF PRODUCTION RECORDS OF THE SUSPECT DEVICE REVEALS NO ANOMALY. CONSEQUENTLY, AVAILABLE EVIDENCE INDICATES THAT THE DEVICE WAS IN SPECIFICATION WHEN RELEASED. ON FEBURARY 12, 2004, EVERY ATTEMPT TO INTERROGATE THE DEVICE RESULTED IN A COMMUNICATION ERROR MESSAGE. THEREFORE, THE DEVICE FAILED TO MEET A SPECIFICATION AFTER USE. ANALYSIS FILES WERE RETRIEVED (FILES SAVED BY THE PROGRAMMER CONTAINING THE RECENT HISTORY OF COMMUNICATIONS WITH THE PROGRAMMING HEAD, THE IMPLANT, AND THE ACTIVATION OF THE USER INTERFACE. THIS FILE IS NOT AVAILABLE BY THE USER BUT THE USER MAY SEND A COPY TO THE MANUFACTURER FOR ANALYSIS). THE ANALYSIS REVEALS THAT THE REPORTED BEHAVIOR RESULTS FROM AN OVERWRITING OF SOME PARAMETERS WITH UNEXPECTED VALUES IN DEVICE MEMORY, INDUCING INABILITY TO INTERROGATE THE DEVICE. THE ORIGIN OF THE REPORTED BEHAVIOR IS A PROGRAMMING HEAD SOFTYWARE INADEQUACY, WHICH CAN OCCUR ONLY IN CASE OF TELEMETRY ERRORS (FOR INSTANCE WHEN THE PROGRAMMING HEAD IS NOT WELL POSITIONED). IN ORDER TO PREVENT THE REOCCURRENCE OF SUCH EVENT, THE HSO SOFTWARE VERSION HAS BEEN IMPROVED IN VERSION HSO 2.66, WHICH IS ALREADY APPROVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP INTERROGATION THIS DEVICE WOULD NOT INTERROGATE. PROGRAMMING FILES WERE REVIEWED AND IT WAS CONCLUDED THAT THE REPORTED BEHAVIOR RESULTED FROM AN OVERWRITING OF PARAMETERS WITH UNEXPECTED VALUES IN DEVICE MEMORY. THE PARAMETER VALUES WERE CORRECTED USING THE ELATERM PROGRAMMING SYSTEM AND THE DEVICE INTERROGATED SUCCESSFULLY AND REMAINS IMPLANTED. NOTE: THIS IS BEING FILED LATE DUE TO ELA MEDICAL GETTING A COMPLETE UNDERSTANDING OF THE REPORTING REQUIREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNMPHONY CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 2550 S031030

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other