BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 3210595 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03204
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 27.6-28.0CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASION WAS NOTED AT 10.7-12.0CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 27.6-28.0CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASION WAS NOTED AT 10.7-12.0CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW UP. EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUOROSCOPY. NO ELECTRICAL ANOMALIES WERE NOTED. THE LEAD WILL BE EXPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309358 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention