BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 2182727 · Received July 8, 2011

    Report

    Report Number
    9610579-2011-00070
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 6, 2011
    Report Date
    June 17, 2011
    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

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE US. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2011 F/U, THE PHYSICIAN OBSERVED THAT THE DAILY MEAN HEART RATE CURVE SHOWED INCONSISTENT INFO (ATRIAL RATE OF 0MIN-1 AND VENTRICULAR RATE OF -103MIN-1) BETWEEN (B)(6) 2010. THE PHYSICIAN WANTS AN EXPLANATION OF THE OBSERVED BEHAVIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 M090320

    Patients

    Seq Age Sex Outcome Treatment
    1