BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 2915511 · Received January 10, 2013

    Report

    Report Number
    1000165971-2013-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, UPON DEVICE INTERROGATION IN ITS BOX ON (B)(6) 2012, THE DEVICE WAS FOUND IN STANDBY MODE, THIS TOOK PLACE IN THE DISTRIBUTOR OFFICE. AN EXPLANATION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13421 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2661

    Patients

    Seq Age Sex Outcome Treatment
    1