BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1830728 · Received September 10, 2010

    Report

    Report Number
    2017865-2010-03298
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    June 28, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S R-WAVES DROPPED. THE PHYSICIAN DECIDED TO SWITCH THE LV AND RV PACE/SENSE PORTION OF THE LEADS. DUE TO THE INABILITY TO INDUCE, THE PHYSICIAN DECIDED TO CONTINUE MONITORING THE PATIENT. THE LEAD REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE LEAD WAS CAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1590/60

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention V-366 464018