BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1050799 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01751
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 20, 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
    WV
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    THE LEAD WAS EXPLANTED DUE TO HIGH THRESHOLDS AND SENSING ANOMALY. THE PHYSICIAN BROKE THE SCREW WHEN TRYING TO REVISE THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention