BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1831002 · Received September 7, 2010

    Report

    Report Number
    9610579-2010-00583
    Event Type
    Injury
    Date Received
    September 7, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 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)(6), 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    AT SCHEDULED FOLLOW-UP, THE DEVICE WAS FOUND IN STANDBY MODE. IT COULD HAVE BEEN RE-INITIALISED; HOWEVER, THE DEVICE COULD NOT BE INTERROGATED AFTERWARDS BECAUSE OF COMMUNICATION ERRORS. THEREFORE, A NEW FOLLOW UP WAS SCHEDULED IN THE IMPLANTATION CENTER: THE DEVICE WAS FOUND AGAIN IN STANDBY MODE. THE RE-INITIALISATION WAS PERFORMED WITH THE STANDARD PROGRAMMER, AND NORMAL OPERATION WAS OBSERVED AFTERWARDS. NEVERTHELESS, A FEW DAYS LATER, THE DEVICE SWITCHED A THIRD TIME IN STANDBY MODE; THEREFORE, IT WAS EXPLANTED. DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S051026

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention