BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2230576 · Received August 12, 2011

    Report

    Report Number
    9610579-2011-00088
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 7, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORTEDLY, DURING A FOLLOW-UP, DIFFICULTIES WERE OBSERVED TO INTERROGATE PROPERLY THE PACEMAKER INVOLVED IN THIS MDR REPORT AND BATTERY IMPEDANCE ALERT OCCURRED. IN ADDITION, THE DEVICE WAS FOUND IN VVI MODE INSTEAD OF AAISAFER MODE. THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S061221

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention