BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2962797 · Received February 14, 2013

    Report

    Report Number
    2938836-2013-00108
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    December 17, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0458
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXTERNAL INSULATION ABRASIONS WERE FOUND AT 46.3 - 46.6CM, 47.3 - 47.6CM, AND 48.0 - 48.2CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN ASYMPTOMATIC PATIENT PRESENTED IN THE OR FOR DEVICE CHANGE-OUT DUE TO NORMAL ERI. EXTERNALIZED CONDUCTORS WERE NOTED. NO ELECTRICAL ANOMALIES WERE DETECTED. LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64716 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR