BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3210497 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03284
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE LEAD TIP MEASURING 43.5 CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 7.2-7.3CM, 8.0-9.2CM, AND 9.3-9.7CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. THE ETFE COATING WAS CONTACT AT THESE LOCATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT DUE TO INABILITY TO INTERROGATE THE DEVICE, EXTERNALIZED CONDUCTORS WERE OBSERVED VIA FLUORO. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS EXPLANTED.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THE LEAD WAS THE CAUSE OF THE DEVICE OUTPUT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310174 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1592/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR (B)(4), (B)(4)