BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2962792 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00084
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 25, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD A COMPLETE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    INTERNAL INSULATION ABRASIONS WERE NOTED AT 15.6-16.7CM AND 11.1-12.2CM FROM TIP ELECTRODE. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE NOTED AT 8.3-10.3CM FROM TIP ELECTRODE. ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS NOTED UNDER THE SVC SHOCK COIL AT 18.0-18.5CM, 20.5-21.8CM, AND 22.9-24.7CM FROM THE ELECTRODE. INTERNAL INSULATION ABRASION WAS NOTED UNDER THE SVC SHOCK COIL AT 17.6-17.7CM FROM TIP ELECTRODE. ONE CONDUCTOR WAS MELTED AND THE ETFE COATING WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE REPORTED FIELD EVENT OF LOW HV IMPEDANCE.

    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

    IT WAS REPORTED THAT LOW HVLI, ELEVATED CAPTURE THRESHOLD AND INAPPROPRIATE VF DETECTION DUE TO AFIB WERE OBSERVED. AN ALERT MESSAGE FOR POSSIBLE OUTPUT CIRCUIT DAMAGE AFTER AN ABORTED SHOCK WAS RECORDED. HV LEAD ANOMALY WAS SUSPECTED. THE ICD AND RV LEAD WAS REPLACED, AND THE LEAD WAS CAPPED AND ABANDONED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT THE BALANCE OF THE LEAD THAT WAS INITIALLY RECEIVED IN (B)(6) 2013, WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64453 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)