BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY

    MDR report key: 1930061 · Received November 18, 2010

    Report

    Report Number
    1000165971-2010-00985
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 4, 2010
    Manufacturer
    SORIN BIOMEDICA CRM., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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

    JUST AFTER IMPLANTATION ON (B)(6), 2010, THE PHYSICIAN OBSERVED A VENTRICULAR PAUSE ON AN ECG SCREEN. IN ADDITION, SOME DAYS AFTER THE IMPLANTATION, HE OBSERVED THAT THE 08:00 AM SAFER SWITCH ATTEMPT WAS PERFORMED A FEW MINUTES AFTER MIDNIGHT PHYSICIAN REQUESTED AN ANALYSIS OF THESE OBSERVATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM., S.R.L. REPLY DR 2475

    Patients

    Seq Age Sex Outcome Treatment
    1