BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 2151590 · Received June 24, 2011

    Report

    Report Number
    9610579-2011-00060
    Event Type
    Malfunction
    Date Received
    June 24, 2011
    Date of Event
    May 23, 2011
    Report Date
    June 7, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING THE F/U PERFORMED ON (B)(6) 2011, A MESSAGE WAS VISIBLE ON THE SCREEN DURING THRESHOLD MEASUREMENT WHEN THE PRINTING COMMAND WAS PROCESSED. WHEN THE MESSAGE WAS VALIDATED, THE THRESHOLD PROCEDURE HAD CONTINUED SUCCESSFULLY. THE TECHNICIAN WANTED A CLARIFICATION ABOUT HOW A MESSAGE RELATED TO PRINTING COULD APPEAR DURING A THRESHOLD PROCEDURE. SHE WAS ALSO WORRIED ABOUT THE SITUATION WHEN A HIGH THRESHOLD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S060227

    Patients

    Seq Age Sex Outcome Treatment
    1