BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3101051 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01843
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    February 27, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    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. EXTERNAL INSULATION ABRASIONS FOUND AT 40.5CM-41.0CM AND 43.0CM-43.7CM FROM THE TIP ELECTRODE, CONSISTENT WITH LEAD FRICTION TO THE ICD. INTERNAL INSULATION ABRASIONS NOTED AT 8.3-9.2CM AND 10.2-11.1CM FROM THE TIP ELECTRODE. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 22.2-24.5CM FROM THE TIP ELECTRODE. THE ETFE COATING WAS INTACT. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 26.5-27.8CM FROM THE TIP ELECTRODE. THE ETFE COATING OF THE SVC CONDUCTORS WAS ABRADED. (B)(4). NO COMPLAINT RECEIVED.

    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
    203176 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1