BEUDAMED
    FDA Adverse Event Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1010559 · Received March 10, 2008

    Report

    Report Number
    2017865-2008-01255
    Date Received
    March 10, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD DID NOT REVEAL ANY CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED NOISE. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. VISUAL INSPECTION REVEALED AN ABRASION AT 51 CM FROM THE CONNECTOR PIN, EXPOSING THE ETFE CABLES BUT NOT ABRADED IN THIS AREA. THE ABRASION IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWS LEAD REMAINS IMPLANTED.

    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 1590/60

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention