BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPRIT

    MDR report key: 2190978 · Received July 29, 2011

    Report

    Report Number
    1000165971-2011-00268
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 13, 2011
    Manufacturer
    SORIN CRM S.R.L.
    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

    CONNECTIONS ISSUES WITH THE SUBJECT DEVICE WERE REPORTED BY THE PHYSICIAN DURING AN IMPLANT ATTEMPT. REPORTEDLY, THE VENTRICULAR LEAD COULD NOT BE PROPERLY SECURED IN THE HEADER, SINCE NO SCREWDRIVER CLICKING SOUND WAS OBTAINED, AND THERE WAS NO RESISTANCE ON THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT NVZ SORIN CRM S.R.L. ESPRIT DR 2511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention