BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 2902677 · Received January 8, 2013

    Report

    Report Number
    2017865-2013-00353
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 21, 2012
    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

    A PARTIAL LEAD WITH THE LEAD TIP MEASURING 51.5CM WAS RETURNED FOR ANALYSIS. EXTERNALIZED CONDUCTORS DUE TO INTERNAL INSULATION ABRASION WERE FOUND AT 11.3 - 15.8CM FROM THE ELECTRODE TIP. THE ETFE COATING WAS INTACT. AN INTERNAL INSULATION ABRASION WAS NOTED AT 11.3 - 12.5CM FROM THE ELECTRODE TIP. THE ETFE COATING WAS INTACT AT THIS LOCATION.

    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

    IT WAS REPORTED THAT DURING DEVICE CHANGE-OUT DUE TO ERI, 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
    9276 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR