BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 3884759 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12216
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 25.6-26.1CM, 26.6-26.9CM, 26.3-26.9CM, AND 27.1-27.9CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 11.5-13.6CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 35.7-36.1CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. THE ETFE COATING WAS ABRADED AT THIS LOCATION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT HIGH PACING THRESHOLD WAS ALSO OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE CLINIC FOR ROUTINE FOLLOW UP. DURING INTERROGATION, ATRIAL AND RV OVERSENSING WERE OBSERVED. IT WAS STATED THAT THE NOISE APPEARS TO BE CAUSED BY THE LEADS RUBBING TOGETHER. LEAD REVISION WAS RECOMMENDED. THE LEAD REMAINS IMPLANTED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360687 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention (B)(4)