BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2230533 · Received August 12, 2011

    Report

    Report Number
    9610579-2011-00087
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 19, 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
    IT
    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, THE PHYSICIAN ATTEMPTED TO IMPLANT THE PACEMAKER INVOLVED IN THIS MDR REPORT BUT DUE TO CONNECTION ISSUES MET AT THE VENTRICULAR LEVEL, THE DEVICE WAS NOT IMPLANTED. IT WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S100512

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention