BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1550828 · Received November 18, 2009

    Report

    Report Number
    1000165971-2009-00061
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Date of Event
    October 19, 2009
    Report Date
    November 17, 2009
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 US.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER P950029. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    CONNECTION ISSUES DURING THE IMPLANTATION PROCEDURE; THEREFORE, THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY DXY - IMPLANTABLE CARDIAC PACEMAKER DXY SORIN BIOMEDICA C.R.M., S.R.L. FACIL DR 2350

    Patients

    Seq Age Sex Outcome Treatment
    1