BEUDAMED
    FDA Adverse Event Death Summary report: N

    PARADYM

    MDR report key: 3558310 · Received October 31, 2013

    Report

    Report Number
    1000165971-2013-00510
    Event Type
    Death
    Date Received
    October 31, 2013
    Report Date
    October 11, 2013
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    NIK
    PMA / PMN Number
    G120093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (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 SUBJECT DEVICE INVOLVED IN A CLINICAL STUDY WAS EXPLANTED AND WILL BE RETURNED FOR A POST-MORTEM ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561451 PARADYM NIK SORIN GROUP ITALIA S.R.L. PARADYM RF SONR 9770 2614

    Patients

    Seq Age Sex Outcome Treatment
    1 Death