BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1881877 · Received October 8, 2010

    Report

    Report Number
    9610579-2010-00596
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 5, 2010
    Report Date
    September 15, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING SCHEDULED FOLLOW UP, THE DEVICE WAS INTERROGATED AND THE PHYSICIAN REQUESTED EXPLANATIONS ABOUT SOME EPISODES RECORDED IN THE DEVICE MEMORY: ON (B)(6), 2010, A SWITCH IN AALSAFER MODE DID NOT OCCUR AFTER 7 LONG PR + V AND THE VENTRICLE WAS PACED ON ONE CYCLE ABOVE THE PROGRAMMED MAXIMUM RATE; ON (B)(6), 2010, A SWITCH IN AALSAFER MODE OCCURRED DUE TO AVB3 CRITERIA; HOWEVER, MORE THAN 7 LONG PR WERE NOTICED AND THERE WAS NO SWITCH ON AVB1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S050414

    Patients

    Seq Age Sex Outcome Treatment
    1