BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 2821018 · Received October 26, 2012

    Report

    Report Number
    1000165971-2012-00405
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 12, 2012
    Manufacturer
    SORIN CRM S.R.L.
    Product Code
    NVZ
    PMA / PMN Number
    P950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE SUBJECT DEVICE WAS IMPLANTED WITH TWO BIPOLAR LEADS. UPON INITIAL INTERROGATION - AFTER THE IMPLANTATION - THE PACEMAKER WAS FOUND IN FALLBACK MODE SWITCH WITH A HIGH VENTRICULAR LEAD IMPEDANCE (ABOVE 3KO). REPORTEDLY, A MESSAGE STATING THE LEAD WAS UNIPOLAR WAS ALSO DISPLAYED; IN ADDITION, ABSENCE OF SENSING WAS OBSERVED IN BOTH CHANNELS AND THE VENTRICULAR PACING THRESHOLD TEST COULD NOT BE PERFORMED. THE PHYSICIAN DECIDED TO REPLACE THE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLY NVZ SORIN CRM S.R.L. REPLY DR 2634

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention