BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIATA PASSIVE FIXATION

    MDR report key: 2242789 · Received September 10, 2011

    Report

    Report Number
    2017865-2011-06007
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    July 5, 2011
    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). NO COM PLAINT RECEIVED WITH RETURN OF DEVICE. FAILURE (EVENT) OBSERVED DURING ANALYSIS. ANALYSIS FOUND INSULATION ABRASION AT 13.9CM - 14.1CM FROM THE CONNECTOR PIN, EXPOSING THE RING ELECTRODE CABLES. THE ABRASION IS CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN.

    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 PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1570/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1