BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 2802408 · Received October 19, 2012

    Report

    Report Number
    1000165971-2012-00395
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 27, 2012
    Report Date
    October 4, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, FEW DAYS AFTER IMPLANTATION ON (B)(6) 2012, THE PHYSICIAN OBSERVED LOSS OF CAPTURE AND SENSING DECREASE. A SYSTEM REVISION WAS PERFORMED ON (B)(6) 2012. NEVERTHELESS, LOSS OF CAPTURE AND SENSING DECREASE RE-APPEARED THE DAY AFTER THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT NVZ SORIN CRM S.R.L. ESPRIT DR 2631

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention