BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1881858 · Received October 8, 2010

    Report

    Report Number
    1000165971-2010-00935
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    July 14, 2010
    Report Date
    September 21, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    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

    THE USER REQUESTED EXPLANATIONS ABOUT POTENTIAL INCONSISTENCY BETWEEN THE PROGRAMMED ATRIAL SENSITIVITY (0.6 MV) AND THE RECORDED DATA IN AIDA MEMORY (HISTOGRAM OF PWAVES WERE DISPLAYED AT 1MV).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY SR 2452

    Patients

    Seq Age Sex Outcome Treatment
    1