BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901279 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12695
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 21.5CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE SHOCK THERAPY DUE TO LEAD NOISE. FLUOROSCOPY REVEALED EXTERNALIZED CONDUCTORS. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT CONDITION IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380808 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention