BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 2984194 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00375
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 20, 2012
    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. RELIABILITY LABORATORY TECHNICIAN; ST JUDE MEDICAL CRMD RELIABILITY LABORATORY; FAILURE (EVENT) OBSERVED DURING ANALYSIS. AN ENTIRE LEAD WAS RETURNED CUT IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 36.4-36.5CM FROM THE HELIX END, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THE SAME LOCATION.

    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
    86089 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7001/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1