BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3901336 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12721
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    April 17, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: EXTERNAL INSULATION ABRASION WAS NOTED AT 8.0-8.2CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE RV CONDUCTOR WAS EXPOSED AT THIS LOCATION. EXTERNAL AND INTERNAL INSULATION ABRASION WAS NOTED AT 15.0-15.7CM FROM THE DISTAL TIP. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 8.5-14.5CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE CHANGE OUT FOR ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT WAS FINE BEFORE AND AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379942 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1