BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1073025 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02275
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 3, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED LOW SENSING AND HIGH PACING THRESHOLD. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. LEAD IMPEDANCE WAS MEASURED AND WAS NORMAL. MECHANICAL AND VISUAL INSPECTION FOUND THE HELIX COULD NOT BE EXTENDED DUE TO BODY FLUID/TISSUE IN THE LEAD DISTAL COIL AND THE HELIX. AFTER DESTRUCTIVE ANALYSIS AND CLEANING, THE HELIX WAS FOUND TO FUNCTION NORMALLY ON THE REMAINING PORTION OF LEAD.

    Description of Event or Problem · 1

    LOW R-WAVES AND AN INCREASE IN PACING THRESHOLD WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention