BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 3642601 · Received December 20, 2013

    Report

    Report Number
    1000165971-2013-00590
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 13, 2013
    Report Date
    December 3, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2013, 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 PARADYM RF CRT MODELS APPROVED UNDER P060027. ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    REPORTEDLY, THE PROGRAMMER USER INTERFACE FROZE DURING A FOLLOW-UP SESSION. THE PROGRAMMER WAS RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669707 PARADYM NIK SORIN GROUP ITALIA S.R.L. PARADYM RF SONR 9770 2712

    Patients

    Seq Age Sex Outcome Treatment
    1