BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1935947 · Received December 8, 2010

    Report

    Report Number
    1000165971-2010-01007
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    SORIN BIOMEDICA C.R.M., S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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

    CONNECTION ISSUES ASSOCIATED WITH THE ATRIAL CHANNEL DURING THE IMPLANTATION PROCEDURE; THEREFORE, THE DEVICE WAS NOT IMPLANTED. ANOTHER PACEMAKER WAS SUBSEQUENTLY IMPLANTED. THE PHYSICIAN HAS WATCHED THE ASSOCIATED VIDEO POSTED ON THE COMPANY WEBSITE, AND AS INDICATED, THE RECOMMENDED METHODS WERE APPLIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN BIOMEDICA C.R.M., S.R.L. REPLY DR 2470

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention