BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS PLUS VR

    MDR report key: 1305803 · Received January 23, 2009

    Report

    Report Number
    1305803
    Event Type
    Malfunction
    Date Received
    January 23, 2009
    Date of Event
    December 1, 2008
    Report Date
    January 23, 2009
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD LVAD (HEARTMATE-2) PLACEMENT. HIS ICD WAS INITIALLY IMPLANTED FOR PRIMARY PREVENTION OF SUDDEN CARDIAC DEATH 3 YEARS PRIOR. PREOPERATIVELY HIS DEVICE WAS NOTED TO HAVE NORMAL FUNCTION, HOWEVER IMMEDIATELY POST LVAD IMPLANTATION; WE WERE NOT ABLE TO ESTABLISH TELEMETRY WITH HIS ICD. FAILURE OF TELEMETRY WITH ST. JUDE ICDS DUE TO RADIOFREQUENCY INTERFERENCE FROM HEART MATE II LVADS HAS BEEN PREVIOUSLY DESCRIBED IN THE LITERATURE (J.C. MATTHEWS, M.D. ET AL., J CARDIOVASC ELECTROPHYSIOL, VOL. 18, PP 1107-1108, OCTOBER 2007). THE PATIENT WAS SEEN AND EXAMINED BY AN ELECTROPHYSIOLOGY STAFF PHYSICIAN AND DEEMED APPROPRIATE FOR A GENERATOR CHANGE TO RESOLVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATLAS PLUS VR DEBRILLATOR, ICD LWS ST. JUDE MEDICAL V-193 *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR