BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3220271 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04207
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 15, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6). (B)(4). EXTERNAL INSULATION ABRASION FOUND AT 7.0-8.5CM FROM HELIX, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. ETFE COATING WAS ABRADED AND THE CABLE WAS FRACTURED. EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION ABRASION FOUND AT 9.1-11.2CM FROM HELIX, CONSISTENT WITH FRICTION TO FRICTION TO ANOTHER DEVICE. THE ETFE COATING INTACT.

    Additional Manufacturer Narrative · 1

    CORRECTION: EXTERNAL INSULATION ABRASION FOUND AT 7.0-8.5CM FROM HELIX, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. ETFE COATING WAS ABRADED AND THE CABLE WAS FRACTURED. EXTERNALIZED CONDUCTORS DUE TO EXTERNAL INSULATION ABRASION FOUND AT 9.1-11.2CM FROM HELIX, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE. ETFE COATING INTACT.

    Description of Event or Problem · 1

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321106 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1