BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1050813 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01759
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 27, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS REMOVED DUE TO PERFORATION. HIGH LEAD IMPEDANCE WAS OBSERVED AS WELL AS POOR SENSING AND PACING THRESHOLDS. NOISE WAS NOTED DURING INAPPROPRIATE THERAPY DELIVERY. THE LEAD WAS EXPLANTED.

    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