BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC DR V-235 DUAL-CHAMBER DEFIBRILLATOR

    MDR report key: 521221 · Received April 15, 2004

    Report

    Report Number
    2938836-2004-00248
    Event Type
    Injury
    Date Received
    April 15, 2004
    Date of Event
    March 24, 2004
    Report Date
    March 24, 2004
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 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 81 YR Other MEDTRONIC 5076, MEDTRONIC 6947, THERAPY| DATES: NA.