BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1762978 · Received June 30, 2010

    Report

    Report Number
    1000165971-2010-00782
    Event Type
    Malfunction
    Date Received
    June 30, 2010
    Date of Event
    June 2, 2010
    Report Date
    June 3, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE REVIEW OF AVB EPISODES RECORDED IN THE PT F/U DATA REVEALED THAT NO VS MARKER WAS DISPLAYED WHEREAS QRS COMPLEX WAS VISIBLE ON THE ECG WHEN THE PACING MODE WAS BEING CHANGED FROM AAI TO DDD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY DR 2348

    Patients

    Seq Age Sex Outcome Treatment
    1