BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1073027 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02277
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    December 20, 2007
    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
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF QUALITY RECORDSTHE HELIX WAS FOUND TO BE CLOGGED WITH BLOOD AND TISSUE. THE","LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO INFECTION.

    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 7020/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention