BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RHAPSODY +

    MDR report key: 1935942 · Received December 8, 2010

    Report

    Report Number
    9610579-2010-00630
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 18, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING A SCHEDULED FOLLOW UP, THE DEVICE WAS FOUND IN STANDBY MODE. REINITIALIZATION ATTEMPTS DID NOT SUCCEED AND "TELEMETRY ERROR" MESSAGES WERE DISPLAYED. THEREFORE THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHAPSODY + NVZ SORIN CRM RHAPSODY + DR 2530 S040617

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention