BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLY 200

    MDR report key: 4212334 · Received October 30, 2014

    Report

    Report Number
    1000165971-2014-00601
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    September 20, 2014
    Report Date
    October 2, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 P950029.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP PERFORMED ON (B)(6) 2014, THE PROGRAMMER USER INTERFACE (ORCHESTRA PLUS, SN: (B)(4)) FROZE. THE THRESHOLD TEST ALSO FROZE TWICE DURING THE FOLLOW UP (STILL BEING ABLE TO MOVE THE CURSOR / ARROW AROUND THE SCREEN). THE USER HAD TO SWITCH OFF AT THE MAINS AND RESTART AFTER EACH INCIDENCE.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP PERFORMED ON (B)(6) 2014, THE PROGRAMMER USER INTERFACE (ORCHESTRA PLUS, SN: (B)(4) ) FROZE TWICE DURING THE THRESHOLD TEST (STILL BEING ABLE TO MOVE THE CURSOR / ARROW AROUND THE SCREEN). THE USER HAD TO SWITCH OFF AT THE MAINS AND RESTART AFTER EACH INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695560 REPLY 200 NVZ SORIN GROUP ITALIA S.R.L. - CRM FACILITY REPLY 200 SR S0017

    Patients

    Seq Age Sex Outcome Treatment
    1