BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY 200

    MDR report key: 3986430 · Received August 7, 2014

    Report

    Report Number
    1000165971-2014-00452
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    March 24, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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, DURING THE IMPLANTATION PROCEDURE, PACING INHIBITION DUE TO THE USE OF ELECTROSURGERY WAS OBSERVED. THE ELECTROSURGERY WAS SWITCHED OFF AFTERWARDS BUT THE PACING INHIBITION STILL OBSERVED FOR A FEW SECONDS. NOTE THAT THE PATIENT IS PACEMAKER-DEPENDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464589 REPLY 200 NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200 DR 2793

    Patients

    Seq Age Sex Outcome Treatment
    1