BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL INC.

    MDR report key: 898150 · Received May 23, 2007

    Report

    Report Number
    898150
    Event Type
    Injury
    Date Received
    May 23, 2007
    Date of Event
    April 24, 2007
    Report Date
    April 27, 2007
    Manufacturer
    ST. JUDE MEDICAL INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL FOR RIGHT ATRIAL LEAD EXTRACTION DUE TO FRACTURE OF THE ORIGINAL LEAD, IMPLANTATION OF A NEW ATRIAL PACING AND SENSING LEAD, DEFIBRILLATION THRESHOLD TESTING AND IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR POCKET REVISION. THERE IS A RETAINED FRAGMENT OF THIS LEAD WITH THE HELIX STILL INTACT IN THE PT'S RIGHT ATRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL INC. ATRIAL LEAD LWS ST. JUDE MEDICAL INC. 17822 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention