BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 3900015 · Received June 27, 2014

    Report

    Report Number
    1000165971-2014-00383
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MODEL INVOLVED IN THIS MDR REPORT IS NOT APPROVED IN THE U.S.; HOWEVER, IT IS SIMILAR TO REPLY DR OR SR MODELS APPROVED UNDER (B)(4). PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    AFTER CARDIOVERSION WITH AN EXTERNAL DEFIBRILLATOR, THE PACEMAKER SHOWED NO SENSING ACTIVITY FOR A FEW MINUTES WHILE PACING WAS DELIVERED IN THE ATRIUM AS WELL AS IN THE VENTRICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377377 KORA NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA 100 DR 2756

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention