BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ACTIVE FIXATION LEAD

    MDR report key: 1050878 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01820
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    February 15, 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
    MA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT HAD LEAD REPOSITIONED DUE TO UNACCEPTABLE CAPTURE THRESHOLDS. THE LEAD TIP WAS PLACED IN THE RV OUTFLOW TRACK AND IS CURRENTLY SHOWING GOOD CAPTURE AND SENSING VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ACTIVE FIXATION LEAD NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 1590/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention