BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC DR V-235 DUAL-CHAMBER DEFIBRILLATOR

    MDR report key: 462891 · Received May 28, 2003

    Report

    Report Number
    2938836-2003-00200
    Event Type
    Injury
    Date Received
    May 28, 2003
    Date of Event
    March 7, 2003
    Report Date
    March 7, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 11/13/1997, 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 EPIC DR V-235 DUAL-CHAMBER DEFIBRILLATOR IMPLANTABLE CARDIAC DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-235 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other 1580, THERAPY DATES: NA.