BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX

    MDR report key: 6954431 · Received October 17, 2017

    Report

    Report Number
    6954431
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 5, 2017
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    MRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MALE WITH HISTORY OF HYPERTENSION, HEART DISEASE WITH HEART FAILURE, HYPERCHOLESTEROLEMIA, HYPERTROPHIC CARDIOMYOPATHY. PATIENT WITH A DUAL CHAMBER BIOTRONIK ICD. APPROXIMATELY 2 MONTHS AGO, THE PATIENT RECEIVED 7 INAPPROPRIATE DEVICE DISCHARGES SECONDARY TO LEAD NOISE FROM RIGHT VENTRICULAR LEAD FRACTURE. AT THAT TIME THERAPIES FROM HIS DEVICE WERE DISABLED AND IT WAS RECOMMENDED TO PROCEED WITH SCHEDULED LASER LEAD EXTRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736675 LUMAX DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM BIOTRONIK, INC. 540 DR-T

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR CARDIAC DRUGS.