BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1586480 · Received January 21, 2010

    Report

    Report Number
    1000165971-2009-00134
    Event Type
    Malfunction
    Date Received
    January 21, 2010
    Date of Event
    November 27, 2009
    Report Date
    December 7, 2009
    Manufacturer
    SORIN BIOMEDICA C.R.M., 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

    DECEMBER 21, 2009: THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. THE ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE PROGRAMMER SCREEN FROZE WHEN PATIENT DATA PRINTING WAS BEING LAUNCHED. MOREOVER, AFTER HAVING REBOOT THE PROGRAMMER, THE PATIENT DATA WAS ALSO NOT RECORDED IN THE PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ - PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2378

    Patients

    Seq Age Sex Outcome Treatment
    1