BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 300 HF-T

    MDR report key: 3962034 · Received July 28, 2014

    Report

    Report Number
    1028232-2014-002616
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    March 27, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    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 RETURNED ICD WAS FIRST INTERROGATED. DEVICE STATUS WAS ERI, 253 CHARGING PROCEDURES HAD BEEN RECORDED. THE CONTENTS OF THE ICD MEMORY WERE CHECKED; INTERFERENCE IN THE RIGHT VENTRICULAR CHANNEL WAS APPARENT IN ALL AVAILABLE IEGMS. DEVICE SENSING CAPABILITIES WERE THEN CHECKED AND NO NOISE WAS FOUND. THE ICD RECORDED THE PROVIDED SIGNAL WITHOUT ANY INTERFERENCE. THE THERAPY CAPABILITIES OF THE ICS WERE CHECKED. THE ANTI-BRADYCARDIA OUTPUT SIGNAL WAS PERFECT AND CORRESPONDED TO THE VALUES PROGRAMMED. A FIBRILLATION SIGNAL WAS TRANSMITTED AND THE DEVICE REACTED AS PER SPECIFICATIONS WITH A DEFIBRILLATION SHOCK. THE SPECIFIED LEVEL OF ENERGY WAS ATTAINED. THE CHARGE TIME WAS ALSO REGULAR. THE ICD HAD BEEN IMPLANTED FOR 74 MONTHS AND 253 CHARGING PROCEDURES WERE DOCUMENTED. THE CHARGE FROM THE BATTERY WAS CHECKED. THE BATTERY DEPLETION WAS AS EXPECTED. THE ICD PRODUCTION DOCUMENTS WERE CHECKED. ALL PRODUCTION STEPS WERE CORRECTLY EXECUTED. THERE IS NO INDICATION OF A MATERIALS OR PRODUCTION DEFECT.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 74 MONTHS OVERSENSING WAS REPORTED. THE LEAD AND THE ICD WERE EXPLANTED THEN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437447 LUMAX 300 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 355262

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization