BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLY

    MDR report key: 10697717 · Received October 19, 2020

    Report

    Report Number
    1000165971-2020-00653
    Event Type
    Injury
    Date Received
    October 19, 2020
    Date of Event
    September 17, 2020
    Report Date
    December 8, 2020
    Manufacturer
    MICROPORT CRM 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 · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    REPORTEDLY, ON (B)(6) 2020 AROUND 13:10, THE MESSAGE 'DEVICE RESET WAS NEEDED' WAS DISPLAYED ON THE PROGRAMMER. THE PACEMAKER WAS RE-INITIALIZED AND PROGRAMMED IN SAFER-R MODE IN BIPOLAR CONFIGURATION. OVERSENSING WAS OBSERVED IN AN EPISODE RECORDED IN THE DEVICE MEMORIES. LEADS IMPEDANCES, PACING AND SENSING THRESHOLDS WERE ALL NORMAL AND THE PATIENT WAS PUT UNDER OBSERVATION.

    Description of Event or Problem · 1

    REPORTEDLY, ON (B)(6) 2020 AROUND 13:10, THE MESSAGE 'DEVICE RESET WAS NEEDED' WAS DISPLAYED ON THE PROGRAMMER. THE PACEMAKER WAS RE-INITIALIZED AND PROGRAMMED IN SAFER-R MODE IN BIPOLAR CONFIGURATION. OVERSENSING WAS OBSERVED IN AN EPISODE RECORDED IN THE DEVICE MEMORIES. LEADS IMPEDANCES, PACING AND SENSING THRESHOLDS WERE ALL NORMAL AND THE PATIENT WAS PUT UNDER OBSERVATION. PRELIMINARY ANALYSIS RESULTS CONFIRMED THE REPORTED SWITCH IN STANDBY MODE, MOST PROBABLY DUE TO A SINGLE EVENT UPSET (SEU). THE DEVICE WAS PROPERLY RE-INITIALIZED DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2020 AND ITS NORMAL FUNCTIONING WAS RESTORED. BASED ON PRELIMINARY ANALYSIS, IT IS SUSPECTED THAT THE OVERSENSING EPISODE IS MOST PROBABLY RELATED TO THE ACTIVATION OF THE MV SENSOR DURING THE FOLLOW-UP PERFORMED ON (B)(6) 2020. HOWEVER ATRIAL AND VENTRICULAR LEADS ISSUES COULD NOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163022 REPLY PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MICROPORT CRM S.R.L. REPLY DR 2653

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention