BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY

    MDR report key: 1983878 · Received February 4, 2011

    Report

    Report Number
    9610579-2011-00010
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 24, 2011
    Manufacturer
    SORIN CRM
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FEB 04, 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, 1.5 MONTH AFTER IMPLANTATION OF THE PACEMAKER INVOLVED IN THIS MDR REPORT, THE PT WAS HOSPITALIZED WITH DIZZINESS EPISODES AND SPONTANEOUS RHYTHM 40MIN-1 WITH COMPLETE AV BLOCK (LOSS OF CAPTURE IN THE VENTRICULAR CHANNEL). A TEMPORARY PACEMAKER WAS SUCCESSFULLY IMPLANTED. FURTHER INVESTIGATION SHOWED THAT THE LEAD MEASUREMENTS WERE CORRECT WITH THE PSA ANALYZER; WHEN THE DEVICE WAS CONNECTED AGAIN TO THE LEAD, THE SAME PHENOMENON APPEARED. THE PACEMAKER WAS EXPLANTED AND RETURNED FOR ANALYSIS. ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY NVZ SORIN CRM SYMPHONY DR 2550 S090529

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention