BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 3090102 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01050
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    March 21, 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. (B)(4) - FAILURE (EVENT) OBSERVED DURING ANALYSIS. EXTERNAL INSULATION ABRASION WAS FOUND AT 35.8-36.2CM FROM THE HELIX, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN . THE ETFE COATING WAS INTACT AT THIS LOCATION. INTERNAL INSULATION ABRASION UNDER THE SVC SHOCK COIL WAS NOTED AT 19.0CM-21.2CM FROM THE HELIX. THE E ETFE COATING OF THE RE CONDUCTOR WAS ABRADED AT THIS LOCATION. THIS IS CONSISTENT WITH THE REPORTED FIELD OBSERVATION OF NOISE AND INAPPROPRIATE THERAPY IF THE RE CONDUCTOR CAME INTO CONTACT WITH THE SVC SHOCK COIL.

    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
    192078 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1580/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1