BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ACTIVE FIXATION

    MDR report key: 1727190 · Received June 17, 2010

    Report

    Report Number
    2017865-2010-02312
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    May 13, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMAP950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE FIELD EXPERIENCE WAS CONFIRMED. ANALYSIS FOUND SURFACE ABRASION AT APPROXIMATELY 11.2 CM FROM THE CONNECTOR PIN AND THE PROXIMAL CABLES WERE FRACTURED AT THE SAME AREA. THIS DAMAGE COULD CAUSE THE REPORTED NOISE AND DELIVER INAPPROPRIATE SHOCKS WHEN IN CONTACT WITH THE ICD CAN. THE SURFACE ABRASION AT 11.2 CM IS CONSISTENT WITH THE PRODUCED BY FRICTION WITH THE ICD CAN.

    Description of Event or Problem · 1

    PATIENT WAS HOSPITALIZED FOR CARDIAC FAILURE AND EXPERIENCED VF, AND INAPPROPRIATE SHOCK WAS DELIVERED. THE PATIENT FELL AND LOST CONSCIOUSNESS. A FEW DAYS LATER, PATIENT RECEIVED MORE INAPPROPRIATE SHOCKS. LEAD FRACTURE WAS SUSPECTED. REVIEW OF THE IEGM REVEALED HIGH IMPEDANCE AND NOISE. ON (B) (6) 2010, ANOTHER VF OCCURRED. THE PATIENT LATER EXPIRED.

    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 1580/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death MDT 7278, (B) (4)