BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 2050803 · Received April 1, 2011

    Report

    Report Number
    9610579-2011-00024
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 22, 2011
    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), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    AT FOLLOW-UP ON (B)(6) 2011, THE DEVICE WAS FOUND IN STANDBY MODE. THIS WAS ALREADY THE CASE AT A PREVIOUS FOLLOW-UP PERFORMED ON (B)(6) 2010 (THIS EVENT WAS NOT REPORTED). REPORTEDLY, A 24 HOURS RECORDING PRIOR (B)(6) 2010 FOLLOW-UP SHOWED INTERMITTENT LOSS OF VENTRICULAR CAPTURE AND VENTRICULAR UNDERSENSING. THE COMPLAINANT INDICATED THE DEVICE WOULD BE REPLACED WITHOUT FURTHER DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S060309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention