BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 3050553 · Received April 10, 2013

    Report

    Report Number
    1028232-2013-00914
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    August 19, 2012
    Report Date
    March 26, 2013
    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

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL2. THE DEVICE WAS IMPLANTED FOR 50 MONTHS AND 60 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. DURING THE ANALYSIS OF THE AVAILABLE IEGM'S NOISE WAS OBSERVED IN THE RIGHT VENTRICULAR CHANNEL, WHICH LED TO 43 INAPPROPRIATE CHARGING CYCLES OF WHICH 12 RESULTED IN SHOCK DELIVERY. THEREFORE, A SENSING TEST WAS PERFORMED, AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE ICD TO BE FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. NEXT, THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS IN AMPLITUDE AND FREQUENCY AS PROGRAMMED. A FIBRILLATION SIGNAL WAS APPLIED AND THE DEVICE DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 50 MONTHS, INAPPROPRIATE SHOCKS WERE REPORTED. NO OTHER ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. THE ICD AND THE LEAD WERE REPLACED. AN IMPLANT DATE FOR THIS DEVICE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152754 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization