BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073033 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02283
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 29, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    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 REPORTED HIGH THRESHOLDS WERE NOT CONFIRMED IN THE LABORATORY. ANALYSIS FOUND THE LEAD TO EXHIBIT NORMAL ELECTRICAL CHARACTERISTICS AND IMPEDANCE. FURTHER ANALYSIS", "FOUND THE HELIX COULD NOT BE EXTENDED DUE TO DRIED BODY FLUID IN THE DISTAL COIL AND HELIX. THE LEAD WAS CUT AT 54CM FROM THE CONNECTOR PIN. THE HELIX COULD BE FULLY EXTENDED AND RETRACTED BY APPLYING TORQUE DIRECTLY TO THE DISTAL COIL OF THE REMAINING PORTION. THE HELIX EXTENSION MEASUREMENT WAS WITHIN SPECIFICATION. NO DEFECTS IN MATERIALS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNDERSENSING AND HIGH THRESHOLD WAS OBSERVED. AN X-RAY DID NOT SHOW ANY LEAD MOVEMENT. THE LEAD WAS REMOVED WHEN AN ATTEMPT TO REPOSITION THE LEAD WAS UNSUCCESSFUL. MICRODISLODGMENT WAS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention