BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPL LEAD SYSTEM

    MDR report key: 398512 · Received June 7, 2002

    Report

    Report Number
    2938836-2002-00229
    Event Type
    Injury
    Date Received
    June 7, 2002
    Date of Event
    March 14, 2002
    Report Date
    April 14, 2002
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ICD WAS EXPLANTED DUE TO INFECTION. THE INFECTION IS BEING REPORTED UNDER AN AGREEMENT THAT WAS COMMUNICATED TO FDA ON NOVEMBER 13, 1997, IN WHICH ALL INFECTIONS OCCURRING WITHIN 30 DAYS OF IMPLANT SHALL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPL LEAD SYSTEM TRANSVENOUS LEAD DTB ST. JUDE MEDICAL, INC., CRMD SP02 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other V240, THERAPY DATE: NA.