BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 3901501 · Received June 30, 2014

    Report

    Report Number
    1000165971-2014-00385
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    PMA / PMN Number
    PP950029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A REGULAR FOLLOW-UP PERFORMED ON (B)(6) 2014, ATRIAL IMPEDANCE WAS MEASURED OVER 3000 OHMS IN BOTH UNIPOLAR AND BIPOLAR CONFIGURATIONS. ATRIAL OVERSENSING WAS ALSO OBSERVED IN EPISODES STORED IN DEVICE MEMORIES. VENTRICULAR MEASUREMENTS ARE NORMAL. THE PACING MODE WAS REPROGRAMMED FROM VDD TO VVIR DURING PREVIOUS FOLLOW-UP ((B)(6) 2013).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379771 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY DR 2616

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention