BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 2211135 · Received August 8, 2011

    Report

    Report Number
    9610579-2011-00083
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011, THE PHYSICIAN OBSERVED THAT THE ESTIMATED LONGEVITY WAS 130 MONTHS. HOWEVER ON (B)(6) 2011 THE ESTIMATED LONGEVITY WAS 157 MONTHS. THE PHYSICIAN REQUESTED AN EXPLANATION. PRELIMINARY ANALYSIS HAS SHOWED THAT THE PHYSICIAN HAS CHANGED THE PACING PARAMETERS ON (B)(6) 2011 AND THAT BOTH ESTIMATIONS WERE IN ACCORDANCE WITH THE PROGRAMMED PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S050906

    Patients

    Seq Age Sex Outcome Treatment
    1