BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3022741 · Received March 22, 2013

    Report

    Report Number
    1000165971-2013-00151
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 5, 2013
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2013. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, DURING IMPLANTATION PROCEDURE, THE DEVICE FAILED TO PACE IN BIPOLAR SETTINGS AS EXPECTED WHEN USING AUTOMATIC DETECTION OF IMPLANTATION FEATURE. DEVICE PACED NORMALLY IN UNIPOLAR WHEN PLACED INTO THE POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119642 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2673

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention