BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2133563 · Received June 16, 2011

    Report

    Report Number
    9610579-2011-00058
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) 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 ROUTINE F/U PERFORMED ON (B)(6) 2011, THE DEVICE INVOLVED IN THIS MDR REPORT COULD NOT BE INTERROGATED. HOWEVER, PACING PULSES WERE DELIVERED AT 96 MIN-1 IN DOO MODE WHEN THE MAGNET WAS APPLIED, I.E. THE BATTERY STATUS WAS AT BOL. ATTEMPT TO RESET THE DEVICE WAS PERFORMED, BUT WAS NOT SUCCESSFUL; THEREFORE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 M060821

    Patients

    Seq Age Sex Outcome Treatment
    1