BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 3980157 · Received August 5, 2014

    Report

    Report Number
    1000165971-2014-00442
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PARADYM RF DR MODELS APPROVED UNDER P980049.

    Description of Event or Problem · 1

    REPORTEDLY, DURING SCHEDULED FOLLOW-UP OF THE SUBJECT ICD ON (B)(6) 2014, THE ORCHESTRA PROGRAMMER SCREEN FROZE; THE PROGRAMMER HAD TO BE UNPLUGGED AND REBOOTED TO RESUME THE FOLLOW-UP. AN EXPLANATION IS REQUESTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING SCHEDULED FOLLOW-UP OF THE SUBJECT ICD ON (B)(6) 2014, THE ORCHESTRA PROGRAMMER SCREEN FROZE; THE PROGRAMMER HAD TO BE UNPLUGGED AND REBOOTED TO RESUME THE FOLLOW-UP. AN EXPLANATION IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457807 PARADYM 2 MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 DR 8552 2809

    Patients

    Seq Age Sex Outcome Treatment
    1