BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 1800925 · Received August 10, 2010

    Report

    Report Number
    1000165971-2010-00862
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 30, 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)(4). THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    A CONNECTION PROBLEM WAS SUSTAINED DURING AN IMPLANT ATTEMPT OF THE SUBJECT DEVICE; 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 SR 2409

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention