BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1050861 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01803
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    January 28, 2009
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED CUT IN THREE SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 26.8-27.2CM 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 25.4-29.3CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION WAS NOTED AT 7.6-7.7CM, 12.3-14.2CM, 14.7-15.2CM, 28.0-28.1CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE VENTRICULAR CHANNEL. ISOMETRICS WERE PERFORMED AND NO NOISE WAS NOTED. X-RAYS WERE RECOMENDED. THE LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE LEAD. THE LEAD WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    THE RV PACE/SENSE PORTION OF THE LEAD WAS CAPPED. DEFIB PORTION REMAINS ACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention