BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KORA

    MDR report key: 4201833 · Received October 27, 2014

    Report

    Report Number
    1000165971-2014-00593
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    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 P950029

    Description of Event or Problem · 1

    THE PHYSICIAN STATED THAT DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER, A CONNECTION ISSUE RELATIVE TO THE VENTRICULAR CHANNEL WAS INCURRED. SPECIFICALLY, THERE WAS DIFFICULTY WITH THE ASSOCIATED SET-SCREW.

    Description of Event or Problem · 1

    THE PHYSICIAN THAT DURING AN IMPLANT ATTEMPT OF THE SUBJECT PACEMAKER A CONNECTION ISSUE RELATIVE TO THE VENTRICULAR CHANNEL WAS INCURRED. SPECIFICALLY, THERE WAS DIFFICULTY WITH THE ASSOCIATED SET-SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681758 KORA NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY KORA 100 DR S0037

    Patients

    Seq Age Sex Outcome Treatment
    1