BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE

    MDR report key: 827719 · Received March 5, 2007

    Report

    Report Number
    827719
    Event Type
    Injury
    Date Received
    March 5, 2007
    Date of Event
    January 31, 2007
    Report Date
    February 2, 2007
    Manufacturer
    EPIC DR
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD EROSION OF DEVICE THROUGH SKIN MAKING IT NECESSARY TO REMOVE DEVICE AND LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE ICD LWS EPIC DR V235 24721

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization