BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1073533 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02427
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP, A LOSS OF CAPTURE AND LOW SENSING WERE OBSERVED. PHYSICIAN ELECTED TO REPLACE THE LEAD. THERE WERE NO CONSEQUENCES TO THE PATIENT. THE LEAD WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7000/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention