BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST ACTIVE FIXATION

    MDR report key: 1923464 · Received December 13, 2010

    Report

    Report Number
    2017865-2010-05405
    Event Type
    Death
    Date Received
    December 13, 2010
    Date of Event
    September 5, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. AS RECEIVED, A PARTIAL LEAD WAS RETURNED MEASURING 5.8CM FROM THE CONNECTOR TIP. WITHOUT THE RETURN OF THE ENTIRE LEAD, A FULL EVALUATION COULD NOT BE PERFORMED. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

    Description of Event or Problem · 1

    THERE WAS NO ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. HOWEVER, ANALYSIS OF THE ICD REVEALED THAT THE LEAD WAS POSSIBLY DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7011/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death V-268, (B)(4)