BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 2182870 · Received July 8, 2011

    Report

    Report Number
    9610579-2011-00072
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    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), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATED. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2011 FOLLOW-UP, THE PHYSICIAN OBSERVED THAT IN MOST OF THE RECORDED EPISODES, THE VENTRICULAR PACED OR SENSED EVENTS WERE FOLLOWED CLOSELY BY ATRIAL EVENTS. THESE EVENTS WERE NOT BLANKED BY THE POST VENTRICULAR ATRIAL BLANKING (PVAB - PROGRAMMABLE UP TO 255MS). SUCH BEHAVIOR INDUCED INAPPROPRIATE FALLBACK MODE SWITCHES AND ABNORMAL DDD FUNCTIONING. THE PHYSICIAN ASKED FOR A SOLUTION FOR THIS SPECIAL CASE (BY DEVICE PROGRAMMING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S100112

    Patients

    Seq Age Sex Outcome Treatment
    1