BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2984339 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00282
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    Z0457
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 7.0-9.1CM FROM THE LEAD TIP. INTERNAL INSULATION ABRASIONS WERE FOUND AT 25.8-27.0CM AND 27.8- 28.2CM FROM THE LEAD TIP. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. INTERNAL INSULATION ABRASION WAS FOUND AT 28.5-29.5CM FROM THE LEAD TIP. THE ETFE COATING WAS ABRADED AT THIS LOCATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EXTERNALIZED CONDUCTORS WERE NOTED VIA FLUOROSCOPY. ALL ELECTRICAL MEASUREMENTS WERE NORMAL. LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86218 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1