BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

    MDR report key: 433893 · Received December 18, 2002

    Report

    Report Number
    2938836-2002-00516
    Event Type
    Injury
    Date Received
    December 18, 2002
    Date of Event
    November 11, 2002
    Report Date
    November 11, 2002
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 OCCURING WITHIN 30 DAYS OF IMPLANT SHALL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM LWS ST. JUDE MEDICAL, INC., CRMD V-240 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other CPI 4473, 0155, MEDTRONIC 6996, THERAPY DATES: NA.