BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA

    MDR report key: 2973707 · Received February 20, 2013

    Report

    Report Number
    2973707
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    December 6, 2012
    Report Date
    February 1, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A CARDIAC ECHO THAT REVEALED EXTERNALIZATION OF CONDUCTOR ON RV RIATA LEAD. THIS REQUIRED RV LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74796 RIATA LEAD, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL 1581-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR