BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 4294563 · Received December 3, 2014

    Report

    Report Number
    1000165971-2014-00675
    Event Type
    Malfunction
    Date Received
    December 3, 2014
    Date of Event
    April 18, 2014
    Report Date
    November 4, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. 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 P950029.

    Description of Event or Problem · 1

    REPORTEDLY, THE LEAD WAS NOT WELL FIXED IN CONNECTOR. THE RE-INTERVENTION WAS PERFORMED ON (B)(6) 2014.

    Description of Event or Problem · 1

    REPORTEDLY, THE LEAD WAS NOT WELL FIXED IN CONNECTOR. THE RE-INTERVENTION WAS PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780226 KORA NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA 100 DR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention