BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3944031 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13476
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    June 11, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 27.7-29.7CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT. EXTERNAL INSULATION ABRASION WAS NOTED AT 11.3-12.2CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASION WAS NOTED AT 7.3-8.1CM, 7.3-7.8CM, AND 8.7-9.3CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 5.9-6.6CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES, THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENTS CONDITION IS EXCELLENT AFTER THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP AND EXTERNALIZED CONDUCTORS WERE OBSERVED VIA DIAGNOSTIC IMAGING. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422987 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention