BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1831920 · Received September 7, 2010

    Report

    Report Number
    1000165971-2010-00885
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    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

    REPORTEDLY, DURING THE ROUTINE FOLLOW-UP OF THE DEVICE INVOLVED IN THIS REPORT; AIDA (DEVICE MEMORIES) COULD NEITHER BE RED, NOR PROGRAMMED. NORMAL DEVICE OPERATIONS WERE OBSERVED APART FROM THAT EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY DR 2227

    Patients

    Seq Age Sex Outcome Treatment
    1