BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1073585 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02469
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 17, 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
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED CAPTURE AND IMPEDANCE ANOMALY. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. A STYLET INSERTION TEST ENCOUNTERED AN OBSTRUCTION, 15 CM FROM THE CONNECTOR END. X-RAY ANALYSIS FOUND THE DISTAL COIL OVER-TORQUED, PREVENTING STYLET FROM ADVANCING. THE CONDITION OF THIS DEVICE WAS NOT FOUND TO BE A RESULT OF DEFICIENCY IN MATERIALS OR WORKMANSHIP.

    Description of Event or Problem · 1

    ONE DAY POST-IMPLANT, INCREASE IN CAPTURE AND IMPEDANCE MEASUREMENTS WERE OBSERVED. A LEAD FRACTURE NEAR PACE/SENSE PIN WAS SUSPECTED. THE LEAD WAS EXPLANTED.

    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 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention