BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073549 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02443
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    May 9, 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

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED HE ANALYSIS OF THE LEAD DID NOT REVEAL ANY DEVICE CONDITION THAT WOULD HAVE CONTRIBUTED TO THE REPORTED LEAD PERFORATION. A LEAD TIP STIFFNESS TEST WAS PERFORMED AND WAS FOUND TO BE WITHIN SPECIFICATION. THE ELECTRICAL CHARACTERISTICS OF THE LEAD WERE FOUND TO BE NORMAL. FURTHER ANALYSIS FOUND THE HELIX CLOGGED WITH BODY FLUID/TISSUE, PREVENTING IT FROM ACTUATION. THE ENSUING RESISTANCE MAY HAVE RESULTED IN AN OVER-TORQUE CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD PERFORATED TO THE LUNG. DRAINAGE OF THE LUNGS WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED FAINTING. THE LEAD WAS EXPLANTED. THE PATIENT IS IN STABLE CONDITION AND BEING TREATED IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7021/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R