BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1930081 · Received November 18, 2010

    Report

    Report Number
    9610579-2010-00621
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 29, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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 THE FOLLOW-UP PERFORMED ON (B)(6), 2010, THE PHYSICIAN OBSERVED THAT THE ATRIAL ARRHYTHMIA WAS CONDUCTED TO THE VENTRICLE ON ECG; THE PHYSICIAN REQUESTED EXPLANATIONS WHY THE MODE SWITCH FEATURE WAS NOT WORKING AS EXPECTED, WITH HIGH VENTRICULAR PACING RATE (ABOVE 100 MIN-1, BUT 120 MIN-1, WHICH WAS THE PROGRAMMED MAXIMUM RATE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S090320

    Patients

    Seq Age Sex Outcome Treatment
    1