BEUDAMED
    FDA Adverse Event Death Summary report: N

    ATLAS VR

    MDR report key: 1407631 · Received June 29, 2009

    Report

    Report Number
    2017865-2009-01803
    Event Type
    Death
    Date Received
    June 29, 2009
    Date of Event
    May 10, 2009
    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

    NA

    Additional Manufacturer Narrative · 1

    INTERROGATION FOUND THE DEVICE IN BACK-UP MODE AS RECEIVED. REVIEW OF THE RAM MAP SHOWED THE DEVICE WENT INTO BACK-UP MODE DUE TO A MAXIMUM VOLTAGE SHOCK INTO HIGH IMPEDANCE, AFTER THE REPORTED TIME OF DEATH. AUTOMATED ELECTRICAL TESTING AND TESTING ON THE BENCH FOUND NO ANOMALIES, AND THE DEVICE MET ALL SPECIFICATIONS.

    Description of Event or Problem · 1

    C-CC-CD - COMPONENT DIMENSIONS (COMPONENT FIT OR ALIGNMENT) LOOSE CONNECTION TUBE/STOPCOCK AFTER OPENING PACKAGE. CONNECTION OF IV SET TO IV BAG WAS MADE, THE PRESSURE LINE WAS NOT FLUSHED WHEN THE DISCONNECTION OCCURRED..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED FROM SUDDEN CARDIAC DEATH. THE LAST PRINTOUT RECEIVED WAS DATED MAY 19, 2009 AND THE DEVICE WAS REPORTEDLY IN BACK-UP MODE ON THAT DATE. THERE IS NOT YET ANY INFORMATION REGARDING THE CIRCUMSTANCES OF THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION V-199 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death