BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST ACTIVE FIXATION LEAD

    MDR report key: 1050897 · Received May 27, 2008

    Report

    Report Number
    2017865-2008-01840
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 28, 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
    MD
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER AND MANDATORY MEDWATCH FORM.

    Description of Event or Problem · 1

    PATIENT PRESENTED IN THE ER WITH SHORTNESS OF BREATH. ECHOCARDIOGRAM CONFIRMED LEAD PERFORATION. THE LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION LEAD NO BNCN FOUND FOR THIS DEVICE LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7002/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention