BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 740 HF-T

    MDR report key: 3758548 · Received April 10, 2014

    Report

    Report Number
    3758548
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 10, 2014
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US

    Narratives

    Description of Event or Problem · 1

    CARDIAC MONITOR SHOWED COARSE V-FIB. THE PATIENT WAS FOUND UNRESPONSIVE. CODE 90 WAS CALLED AND ADVANCED CARDIAC LIFE SUPPORT (ACLS) PROTOCOL WAS INITIATED. THE PATIENT'S RHYTHM THEN CHANGED FROM AV PACED TO A-FIB AND FOR ABOUT 12 MINUTES THERE WERE INTERMITTENT PACER SPIKES AND NO SHOCK FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). CODE BLUE WAS CALLED AND CPR WAS INITIATED, HOWEVER, THE PATIENT DID NOT HAVE RETURN OF SPONTANEOUS CIRCULATION (ROSC) AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216327 LUMAX 740 HF-T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK BIOTRONIK, INC. 740 HF-T *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R