BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 300 VR-T

    MDR report key: 6078918 · Received November 4, 2016

    Report

    Report Number
    1028232-2016-04182
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    March 17, 2016
    Report Date
    October 17, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD FIRST UNDERWENT A STATUS INTERROGATION, DURING WHICH THE DEVICE STATUS ERI WAS DISPLAYED. FIFTY-THREE CHARGE PROCESSES HAD BEEN DOCUMENTED. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED. THE BATTERY DEPLETION PROVED TO BE WITHIN EXPECTATIONS. THE ANALYSIS OF THE AVAILABLE IEGMS SHOWED INTERFERENCE SIGNALS IN THE VENTRICULAR CHANNEL. THE SIGNAL SENSING OF THE DEVICE WAS THEN TESTED, WHICH PROVED TO BE FREE OF NOISE. THE ICD SENSED SUPPLIED SIGNALS FREE OF INTERFERENCE. THE ICD'S ABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS SUPPLIED, AND THE DEVICE REACTED ACCORDING TO SPECIFICATION WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CHARGE TIME PROVED TO BE UNREMARKABLE. IN SUMMARY, THE DEVICE STATUS ERI WAS AS EXPECTED. THERE WAS NO DEVICE DEFECT.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN ESTIMATED IMPLANTATION TIME OF 76 MONTHS, VENTRICULAR OVERSENSING WITH INAPPROPRIATE SHOCKS WERE REPORTED. THE LEAD AND THE ICD WERE EXPLANTED. ALSO, WE WERE INFORMED THAT THE PREVIOUS RV LEAD, THAT HAD BEEN DEACTIVATED IN 2010 DURING A DEVICE EXCHANGE BECAUSE OF OVERSENSING, WAS ALSO REMOVED DURING THIS EXPLANTATION. THE ICD AND THE TWO LEADS WERE RETURNED TO BIOTRONIK FOR ANALYSIS. ASIDE FROM THE SHOCK DELIVERIES, NO OTHER DETERIORATION OF THE PATIENT'S STATE OF HEALTH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729834 LUMAX 300 VR-T ICD LWS BIOTRONIK SE & CO. KG 355270

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization