BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESPIRIT

    MDR report key: 3190194 · Received June 21, 2013

    Report

    Report Number
    1000165971-2013-00304
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    June 7, 2013
    Manufacturer
    SORIN GROUP ITALIA 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). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY HIGH ATRIAL LEAD IMPEDANCES, PACING AND SENSING FAILURE WERE NOTED TOT THE SUBJECT PACEMAKER. A PACEMAKER REVISION WAS PERFORMED ACCORDINGLY. THE LEAD WAS CHECKED WITH A PSA AND WAS KEPT IMPLANTED, THE PACEMAKER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283161 ESPIRIT NVZ SORIN GROUP ITALIA S.R.L. ESPRIT DR 2645

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention