BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS II PLUS DR

    MDR report key: 2781464 · Received October 10, 2012

    Report

    Report Number
    2017865-2012-08929
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    DEVICE FUNCTION WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND ALL TESTS WERE NORMAL. THE DEVICE WAS NORMAL AND NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE MEDICAL ISSUES AND EXPIRED AT HOME. IT WAS BELIEVED THAT THE PATIENT MAY HAVE HAD AN ANEURYSM. THERE IS NO ALLEGATION FROM A HEALTH PROFESSIONAL THAT THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS II PLUS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-268 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death (B)(4)