BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1223710 · Received November 10, 2008

    Report

    Report Number
    2017865-2008-03544
    Event Type
    Injury
    Date Received
    November 10, 2008
    Date of Event
    July 28, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP95022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD EXPERIENCE OF LOW LEAD IMPEDANCE WAS NOT CONFIRMED IN THE LABORATORY. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS AND IMPEDANCE. ANALYSIS FOUND SEPARATION OF THE LEAD BODY DISTAL INSULATION AT THE DISTAL RING ELECTRODE. THE UNDAMAGED AREA OF THE LEAD BODY WAS MEASURED AND FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOW IMPEDANCE WAS OBSERVED. THE LEAD WAS REPLACED. IT WAS NOTED THAT THE LEAD TIP WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention