BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 3201664 · Received June 28, 2013

    Report

    Report Number
    9610579-2013-00047
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MFG AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE SCHEDULED DEVICE REPLACEMENT, COATING SEEMED PEELING OFF AND FLAKING FROM THE TITANIUM CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295663 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S030910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention