BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3784976 · Received February 7, 2014

    Report

    Report Number
    1000165971-2014-00056
    Event Type
    Malfunction
    Date Received
    February 7, 2014
    Date of Event
    December 16, 2013
    Report Date
    January 14, 2014
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    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 US; HOWEVER, IT IS SIMILAR TO PARADYM RF CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    THE REMOTE REPORT OF (B)(6) 2014 SHOWED RED WARNING FOR LEADS, BUT LEADS IMPEDANCES WERE WITHIN NORMAL RANGE. ACCORDING TO PRELIMINARY ANALYSIS RESULTS, THE RED WARNING WAS TRIGGERED BY A LOW P WAVE MEASUREMENT. THIS BEHAVIOR COMPLIES WITH SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81152 PARADYM NIK SORIN GROUP ITALIA S.R.L. PARADYM RF SON R 9770 2558

    Patients

    Seq Age Sex Outcome Treatment
    1