BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RHAPSODY

    MDR report key: 1881870 · Received October 8, 2010

    Report

    Report Number
    9610579-2010-00600
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 28, 2010
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE (B)(4) 2010: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO SYMPHONY DR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    DURING SCHEDULED FOLLOW UP, THIS PACEMAKER DEVICE WAS FOUND IN STANDBY MODE AND WAS RE-INITIALIZED WITH THE STANDARD PROGRAMMER; NORMAL PARAMETERS WERE RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RHAPSODY NVZ SORIN CRM RHAPSODY D 2410 0

    Patients

    Seq Age Sex Outcome Treatment
    1