BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORCHESTRA

    MDR report key: 1831962 · Received September 7, 2010

    Report

    Report Number
    9610579-2010-00581
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 19, 2010
    Manufacturer
    SORIN CRM
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. METHOD: SINCE THE DEVICE REMAINS IMPLANTED, THE PROGRAMMER FILES WERE REVIEWED. THE PROGRAMMER WAS SENT TO THE AFTER SALES SERVICE DEPARTMENT. PLEASE REFER TO THE ATTACHED ANALYSIS REPORT NO. (B)(4) FOR COMPLETE DETAILS. REPORTEDLY, THE FOLLOW-UP OF THE DEVICE (B)(4) WAS INTERRUPTED, AND COULD NOT BE COMPLETED AFTERWARDS, BECAUSE OF A PROGRAMMER FREEZING PROBLEM. ACCORDING TO THE PICTURES OF THE PROGRAMMER SCREEN ATTACHED TO THE COMPLAINT REPORT, ERRORS MESSAGE WERE DISPLAYED, AND A BLUE SCREEN WAS OBSERVED. ANALYSIS OF EXPERTISE FILES LED TO THE FOLLOWING OBSERVATIONS: NO ANOMALY WAS VISIBLE IN THE OPERATIONS OF THE PROGRAMMER SOFTWARE MODULE THAT IS RESPONSIBLE OF THE DEVICE INTERROGATION; THEREFORE, THE IMPOSSIBILITY TO PERFORM A NORMAL FOLLOW-UP OF (B)(4) COULD NOT BE CONFIRMED; NEVERTHELESS, ABNORMAL OPERATIONS WERE VISIBLE IN THE UPPER LAYER OF THE PROGRAMMER SOFTWARE OPERATIONS, I.E. APART FROM THE DEVICE INTERROGATION. THEY PROBABLY EXPLAIN THE ERROR MESSAGES DISPLAYED TO THE USER. CONCLUSION: NO ROOT CAUSE COULD BE IDENTIFIED IN THE PROGRAMMER SOFTWARE OPERATIONS. THE MOST PROBABLE HYPOTHESIS TO EXPLAIN REPORTED EVENT IS A HARDWARE ISSUE WITH THE ORCHESTRA PLUS PROGRAMMER. THE PROGRAMMER SHOULD BE SENT TO AFTER SALES SERVICES FOR REPAIR.

    Description of Event or Problem · 1

    REPORTEDLY, A SYMPHONY DEVICE (SN: (B)(4)) FOLLOW-UP COULD NOT BE PERFORMED NORMALLY BECAUSE THE PROGRAMMER INVOLVED IN THIS REPORT WAS FREEZING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORCHESTRA MRM SORIN CRM ORCHESTRA PLUS

    Patients

    Seq Age Sex Outcome Treatment
    1