BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX

    MDR report key: 3943330 · Received July 10, 2014

    Report

    Report Number
    3943330
    Event Type
    Death
    Date Received
    July 10, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    UNCERTAIN IF AICD DISCHARGED. EMERGENT CATH AT HOSPITAL REVEALED NO OBVIOUS ACUTE MI/ISCHEMIA TO EXPLAIN EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404761 LUMAX DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER NIK BIOTRONIK, INC. 740 DR-T *
    404762 LINOX LEAD RV NVY BIOTRONIK, INC. 65/16 *

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death THE PATIENT PRESENTS IN CARDIAC ARREST. PATIENT| PATIENT WAS SHOCKED ONCE BEFORE EMS ARRIVED.| WITH HX HTN PRESENTING VIA EMS IN CARDIAC ARREST.| HIM, HE WAS IN CARDIAC ARREST. PER EMS REPORT,| PER EMS REPORTS PATIENT SEEN HAVING A SEIZURE AND| COLLAPSED AT CLINIC. WHEN BYSTANDERS TO CHECK ON