BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 6927199 · Received October 7, 2017

    Report

    Report Number
    1000165971-2017-00735
    Event Type
    Malfunction
    Date Received
    October 7, 2017
    Date of Event
    September 7, 2017
    Report Date
    September 7, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED REPORT.

    Description of Event or Problem · 1

    REPORTEDLY THE SUBJECT DEVICE WAS FOUND IN VVI MODE UNIPOLAR AT 70 BPM AND SENSORS WERE OFF. THERE WAS NO WARNING MESSAGE AND THE PARAMETERS REMAINED UNCHANGED IN THE PARAMETER SCREEN.

    Description of Event or Problem · 1

    REPORTEDLY THE SUBJECT DEVICE WAS FOUND IN VVI MODE UNIPOLAR AT 70 BPM AND SENSORS WERE OFF. THERE WAS NO WARNING MESSAGE AND THE PARAMETERS REMAINED UNCHANGED IN THE PARAMETER SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707161 KORA IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA 100 DR S0005

    Patients

    Seq Age Sex Outcome Treatment
    1