BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1915429 · Received November 4, 2010

    Report

    Report Number
    9610579-2010-00612
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 19, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6)2010 - THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, THE PT COMPLAINED THAT THE PACING RATE DIDN'T INCREASE ENOUGH WHEN HE WAS EXERCISING. IN THE MEANTIME, THE MEAN HEART RATE CURVE, TRACKING THE DAILY AVERAGE HEART RATE RHYTHM SINCE THE LAST PT DATA MEMORY RESET, APPEARED TO BE TOO FLAT FOR THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S070118

    Patients

    Seq Age Sex Outcome Treatment
    1