BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT

    MDR report key: 1831961 · Received September 7, 2010

    Report

    Report Number
    1000165971-2010-00883
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 19, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PACEMAKER INVOLVED IN THIS MDR WAS IMPLANTED ON (B)(6) 2009. DURING A FOLLOW-UP PERFORMED ON (B)(6) 2010, THE FOLLOWING DATA WERE OBSERVED: STRANGE LEAD IMPEDANCE TREND GRAPH WAS DISPLAYED BY THE PROGRAMMER: ONLY A BLUE DOTTED LINE APPEARS ON THE X AXIS: HOWEVER, NORMAL IMPEDANCE MEASUREMENTS WERE PERFORMED DURING THE FOLLOW-UP. INCOMPLETE LABEL "S" WAS DISPLAYED IN THE HEADER OF THE PROGRAMMER SCREEN WHEN PORTUGUESE SETTINGS WAS SELECTED, INSTEAD OF THE COMPLETE DEVICE MODEL "ESPRIT S".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESPRIT NVZ SORIN BIOMEDICA CRM S.R.L. ESPRIT S 2402

    Patients

    Seq Age Sex Outcome Treatment
    1