BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPIRIT

    MDR report key: 2040923 · Received March 25, 2011

    Report

    Report Number
    1000165971-2011-00128
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 8, 2011
    Manufacturer
    SORIN CRM S.R.L. - SALUGGIA - ITALY
    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

    MARCH 25, 2011, THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    LEAD CONNECTION ISSUES ASSOCIATED TO THE ATRIAL CHANNEL WERE REPORTED. NO CLICKING SOUND WAS HEARD BY THE PHYSICIAN DURING TIGHTENING OF THE SET-SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPIRIT NVZ SORIN CRM S.R.L. - SALUGGIA - ITALY ESPIRIT DR 2478

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention