BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1073604 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02488
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 24, 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 Location
    AL
    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 DISLODGEMENT. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. MECHANICAL AND VISUAL INSPECTION FOUND THE HELIX IN FULLY EXTENDED POSITION AND CLOGGED WITH BODY FLUID/TISSUE THE ENSUING RESISTANCE MAY HAVE RESULTED IN AN OVER-TORQUE CONDITION. AFTER DESTRUCTIVE ANALYSIS AND CLEANING, THE HELIX WAS FOUND TO FUNCTION NORMALLY. THE HELIX EXTENSION WAS MEASURED AND WAS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED WHEN REPOSITIONING WAS UNSUCCESSFUL DUE TO DISLODGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention