BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3090267 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01077
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 4, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 8.2-8.7CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE ANOTHER DEVICE OR HEART FEATURE. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 10.0-12.7CM AND 37.9-41.3CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE RV SHOCK COIL WAS NOTED AT 6.7-6.9CM FROM THE DISTAL TIP. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 22.5-26.1CM, 23.3-23.4CM, 23.5-23.6CM, AND 25.5-26.4CM FROM THE DISTAL TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 20.0-20.3CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR HEART FEATURE. INTERNAL INSULATION ABRASION WAS NOTED AT 17.3-18.1CM FROM THE DISTAL TIP. THE ETFE COATING WAS ABRADED AT THESE LOCATIONS. THIS IS CONSISTENT WITH THE FIELD COMPLAINT OF OVERSENSING.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE PREVIOUSLY CAPPED LEAD WAS EXPLANTED DUE TO IT'S CLOSE PROXIMITY TO THE NEW LEAD, CAUSING NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED TWO PATIENT NOTIFIERS DUE TO OUT OF RANGE LEAD IMPEDANCE. LOW IMPEDANCE AND OVERSENSING WERE OBSERVED. DURING LEAD REVISION, EXTERNALIZED CONDUCTORS WERE SEEN ON THE LEAD BETWEEN THE RV AND SVC COILS. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192427 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 2207-36 517004