BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA 1580-65

    MDR report key: 5401815 · Received January 27, 2016

    Report

    Report Number
    MW5059803
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    January 21, 2015
    Report Date
    January 27, 2016
    Manufacturer
    ST. JUDE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    A (B)(6) WM WITH NICM, HISTORY OF RECURRENT VT, S/P MDT ICD, NOW NOTED TO HAVE DYSFUNCTIONAL LV LEAD. PATIENT ALSO NOTED TO HAVE STJ RIATA LEAD, ON ADVISORY, AND DEVICE NEARING ERI. HERE TODAY FOR RV LEAD REVISION AND ICD GENERATOR CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53555 RIATA 1580-65 RIATA 1580-65 LWS ST. JUDE 1580-65

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R