BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2210692 · Received August 8, 2011

    Report

    Report Number
    9610579-2011-00082
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 19, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS NOTIFICATION WAS IMPLANTED IN (B)(6) 2007. REPORTEDLY, THE PT WAS HOSPITALIZED IN (B)(6) 2011 AND IT WAS OBSERVED THAT THE DEVICE MALFUNCTIONED. UPON INTERROGATION ON (B)(6) 2011, IT WAS FOUND IN STANDBY MODE AND COULD NOT BE RE-INITIALIZED COMPLETELY. THEREFORE, THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S070305

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention