BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2242791 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06033
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    July 29, 2011
    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
    GA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD MEASURING 42.5CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 5.5-5.8CM PROXIMAL TO PROXIMAL END OF SVC SHOCK COIL, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. INTERNAL INSULATION ABRASIONS WERE NOTED AT 3.2-4.7CM AND 11.5-12.5CM DISTAL FROM THE DISTAL END OF THE SVC SHOCK COIL. INTERNAL INSULATION ABRASION WAS NOTED AT 1.0-2.7CM PROXIMAL FROM THE PROXIMAL END OF THE SVC SHOCK COIL. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 6.2-10.2CM DISTAL FROM THE DISTAL END OF THE SVC SHOCK COIL. THE RV CONDUCTOR ETFE COATING WAS ABRADED AND THE INNER COIL WAS EXPOSED AT THIS LOCATION. THIS IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED ALERTS FOR NOISE. LEAD DAMAGE SUSPECTED.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE PREVIOUSLY CAPPED PORTION WAS LATER EXPLANTED DUE TO AN UNRELATED INFECTION.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE LEAD WAS CAPPED AND REPLACED DUE TO SUBCLAVIAN CRUSH DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1571/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention