BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1050884 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01826
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 13, 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
    NC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    AN ASYMPTOMATIC PATIENT PRESENTED IN THE ER WITH A DEVICE THAT WAS POST-SENSED T-WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY. VARYING R-WAVE AND T-WAVE AMPLITUDES WERE ALSO OBSERVED. THE LEAD WAS CAPPED WHEN OVERSENSING COULD NOT BE REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention