BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1223688 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03562
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    September 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD EXPERIENCE WAS CONFIRMED. ANALYSIS REVEALED AN ABRASION THROUGH THE OUTER INSULATION EXPOSING THE RV CABLES. THE ABRASION IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE ICD CAN. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED WHEN LOW IMPEDANCE WAS OBSERVED AT FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1582/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention