BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1050907 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01851
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 1, 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

    PATIENT PRESENTED TO THE ER AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY. CHEST X-RAY REVEALED THAT THE VENTRICULAR LEAD HAD DISLODGED. THE PATIENT WAS IN ATRIAL FIBRILLATION, AND THE LEAD WORKED UP INTO ATRIUM AND WAS SENSING THE AFIB SIGNALS. THIS CAUSED A VENTRICULAR FIBRILLATION AND RESULTED IN DELIVERING A HIGH VOLTAGE THERAPY. THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION LEAD NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention