BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1934682 · Received November 26, 2010

    Report

    Report Number
    1000165971-2010-00993
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 11, 2010
    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

    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

    DURING THE ROUTINE FOLLOW-UP OF THE DEVICE, A SWITCH TO STANDBY MODE (VVI MODE, 70 MIN-1) WAS OBSERVED. HOWEVER, PRELIMINARY ANALYSIS SHOWED THAT AN UNEXPECTED SWITCH TO NOMINAL PROGRAMMING (VVI MODE, 70 MIN-1) WAS MET DURING A PARAMETER PROGRAMMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY SR 2445

    Patients

    Seq Age Sex Outcome Treatment
    1