BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073034 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02284
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 30, 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 Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED CAPTURE ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. AS RECEIVED, THE HELIX WAS PARTIALLY EXTENDED AND CLOGGED WITH DRIED BLOOD AND TISSUE. X-RAY OF THE IS-1 CONNECTOR REVEALED OVERTORQUE TO THE DISTAL COIL. PHYSICAL DESTRUCTIVE ANALYSIS REVEALED DRIED BLOOD THROUGHOUT THE DISTAL COIL. HELIX EXTENSION LENGTH WAS WITHIN SPECIFICATION. INSULATION DAMAGE NOTED IS CONSISTENT WITH THAT OCCURING DURING THE SURGERY. NO DEFECTS IN MATERIALS NOTED.

    Description of Event or Problem · 1

    A CAPTURE ANOMALY WAS REPORTED. THE LEAD WAS REPLACED WHEN A REPOSITION WAS UNSUCCESSFUL.

    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