BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1955104 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00088
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED ANALYSIS FOUND THAT A PORTION OF THE LEAD WAS RETURNED. INSULATION ABRASIONS WERE NOTED FROM 13.4CM TO 13.7CM AND FROM 15.4CM TO 15.7CM FROM THE CONNECTOR PIN. THE RV CABLES WERE BROKEN AT 15.7CM FROM THE CONNECTOR PIN. THE ABRASIONS FOUND ARE CONSISTENT WITH FRICTION TO THE ICD CAN. OTHER TEXT : NA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD EXHIBITED INTERMITTENT HIGH IMPEDANCE. VISUAL INSPECTION FOUND THAT THE LEAD WAS FRACTURED AND THE CONDUCTOR CABLES WERE EXPOSED OUTSIDE THE INSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1581/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention