BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1930074 · Received November 18, 2010

    Report

    Report Number
    1000165971-2010-00982
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    August 16, 2010
    Report Date
    October 29, 2010
    Manufacturer
    SORIN BIOMEDICA CRM., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6), 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 A F/U PERFORMED ON (B)(6) 2010, THE PHYSICIAN NOTICED UNEXPECTED DISPLAY IN SOME OF THE F/U DATA RECORDED IN DEVICE MEMORIES: THE ATRIAL RECORDED MEAN RATE CURVE WAS SOMETIMES NOT DISPLAYED: AN ATRIAL ARRHYTHMIA EPISODE DURATION DISPLAYED IN THE EPISODE LABEL (MORE THAN ONE DAY) WAS NOT CONSISTENT WITH THE EFFECTIVE RECORD DURATION OF THE EPISODE (FEW MINUTES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM., S.R.L. REPLY DR 2410

    Patients

    Seq Age Sex Outcome Treatment
    1