BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM 2

    MDR report key: 3955023 · Received July 24, 2014

    Report

    Report Number
    1000165971-2014-00422
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED: 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.

    Additional Manufacturer Narrative · 1

    PRELIMINARY ANALYSIS OF THE RETURNED DEVICE CONFIRMED IT OPERATED AS SPECIFIED.

    Additional Manufacturer Narrative · 1

    FINALLY, THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REPLACEMENT PROCEDURE, A CONNECTION ISSUE OCCURED WHEN ATTEMPTING TO CONNECT THE RIGHT VENTRICULAR IS-1 LEAD TIP IN THE SUBJECT ICD. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN CONNECTING THE THREE OTHER LEAD TIPS. FINALLY, THE SUBJECT DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. THE PREVIOUS ONE WAS RECONNECTED TILL ANOTHER REPLACEMENT DEVICE WILL BE IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REPLACEMENT PROCEDURE, A CONNECTION ISSUE OCCURED WHEN ATTEMPTING TO CONNECT THE RIGHT VENTRICULAR IS-1 LEAD TIP IN THE SUBJECT ICD. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN CONNECTING THE THREE OTHER LEAD TIPS. FINALLY, THE SUBJECT DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. THE PREVIOUS ONE WAS RECONNECTED TILL ANOTHER REPLACEMENT DEVICE WILL BE IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REPLACEMENT PROCEDURE, A CONNECTION ISSUE OCCURED WHEN ATTEMPTING TO CONNECT THE RIGHT VENTRICULAR IS-1 LEAD TIP IN THE SUBJECT ICD. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN CONNECTING THE THREE OTHER LEAD TIPS. FINALLY, THE SUBJECT DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. THE PREVIOUS ONE WAS RECONNECTED TILL ANOTHER REPLACEMENT DEVICE WILL BE IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REPLACEMENT PROCEDURE, A CONNECTION ISSUE OCCURRED WHEN ATTEMPTING TO CONNECT THE RIGHT VENTRICULAR IS-1 LEAD TIP IN THE SUBJECT ICD. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN CONNECTING THE THREE OTHER LEAD TIPS. FINALLY, THE SUBJECT DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. THE PREVIOUS ONE WAS RECONNECTED TILL ANOTHER REPLACEMENT DEVICE WILL BE IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REPLACEMENT PROCEDURE, A CONNECTION ISSUE OCCURED WHEN ATTEMPTING TO CONNECT THE RIGHT VENTRICULAR IS-1 LEAD TIP IN THE SUBJECT ICD. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN CONNECTING THE THREE OTHER LEAD TIPS. FINALLY, THE SUBJECT DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. THE PREVIOUS ONE WAS RECONNECTED TILL ANOTHER REPLACEMENT DEVICE WILL BE IMPLANTED.

    Description of Event or Problem · 1

    REPORTEDLY, DURING A REPLACEMENT PROCEDURE, A CONNECTION ISSUE OCCURED WHEN ATTEMPTING TO CONNECT THE RIGHT VENTRICULAR IS-1 LEAD TIP IN THE SUBJECT ICD. IT WAS REPORTED THAT THERE WAS NO PROBLEM WHEN CONNECTING THE THREE OTHER LEAD TIPS. FINALLY, THE SUBJECT DEVICE WAS NOT IMPLANTED AND WILL BE RETURNED FOR ANALYSIS. THE PREVIOUS ONE WAS RECONNECTED TILL ANOTHER REPLACEMENT DEVICE WILL BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434442 PARADYM 2 MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM 2 DR 8552 2805

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention