BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1910501 · Received November 18, 2010

    Report

    Report Number
    1000165971-2010-00980
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    June 24, 2010
    Report Date
    October 28, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    AS REPORTED BY THE PHYSICIAN, THERE WAS NO SILICON INSULATION IN THE CONNECTOR BLOCK IN V-CHANNEL. ANOTHER DEVICE WAS SUBSEQUENTLY IMPLANTED, INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA CRM S.R.L. REPLY DR 2427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention