BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1955149 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00169
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    September 8, 2010
    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 ANALYSIS FOUND AN OUTER INSULATION ABRASION AT 4.8CM FROM THE CONNECTOR PIN, EXPOSING THE IS-1 PROXIMAL COIL. THE DAMAGE FOUND IN THIS AREA IS CONSISTENT WITH FRICTION TO THE ICD CAN. AN OUTER INSULATION ABRASION WAS ALSO NOTED AT 8.0CM FROM THE HELIX END. THE INSULATIONS OF THE IS-1 PROXIMAL AND DF-1 RV CABLES WERE EXPOSED IN THIS AREA. RELIABILITY LABORATORY TECHNICIAN; (B)(4). FAILURE (EVENT) OBSERVED DURING ANALYSIS. LATE DUE TO RE-EVALUATION OF EVENT.

    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
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1