BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT

    MDR report key: 3658018 · Received November 15, 2013

    Report

    Report Number
    1000165971-2013-00539
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Date of Event
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DXY
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013. 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

    REPORTEDLY, DURING A REGULAR PACEMAKER CHECK, IT WAS NOTICED THAT NO DIAGNOSIS DATA WERE AVAILABLE. AN EXPLANTATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594547 ESPRIT NVZ DXY SORIN GROUP ITALIA S.R.L. ESPRIT D 2712

    Patients

    Seq Age Sex Outcome Treatment
    1