BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMPHONY

    MDR report key: 1930091 · Received November 18, 2010

    Report

    Report Number
    9610579-2010-00620
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    July 20, 2010
    Report Date
    November 9, 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 ON (B)(6) 2009, THE RESIDUAL LONGEVITY DISPLAYED BY THE PROGRAMMER WAS AT 111 MONTHS; ON (B)(6) 2010, IT WAS AT 195 MONTHS. THE PHYSICIAN REQUESTED AN EXPLANATION ABOUT THESE VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 M081201

    Patients

    Seq Age Sex Outcome Treatment
    1