BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2230579 · Received August 12, 2011

    Report

    Report Number
    1000165971-2011-00294
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 4, 2011
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), 2011. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING THE IMPLANT ATTEMPT OF THE SUBJECT DEVICE CONNECTION PROBLEMS IN THE ATRIAL CHANNEL OCCURRED. WHEN ENGAGING THE ATRIAL SET SCREW "IT FELT LOOSE" AND THERE WAS NO CLICKING NOISE. WITH SOME EFFORT THE PHYSICIAN WAS ABLE TO TIGHTEN THE SET SCREW, AND A PULL TEST SUGGESTED THAT THERE WAS APPROPRIATE CONNECTION. TO ENSURE THE ATRIAL LEAD WAS PROPERLY CONNECTED, A SEPARATELY PACKAGE SCREWDRIVER WAS OPENED AND CLICKING OF THE SCREWDRIVER WAS OBTAINED, VERIFIED BY THE LEAD PULL TEST. THE SUBJECT DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention