BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 640 VR-T DX PROMRI

    MDR report key: 4504590 · Received February 10, 2015

    Report

    Report Number
    1028232-2015-000324
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    November 2, 2014
    Report Date
    January 28, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD FIRST UNDERWENT A STATUS INTERROGATION, WHICH CONFIRMED THE DEVICE STATUS EOS. THE ICD HAD BEEN IMPLANTED FOR A PERIOD OF 15 MONTHS, AND 11 CHARGE PROCESSES HAD BEEN DOCUMENTED. AS PART OF THE ELECTRICAL ANALYSIS, THE MEMORY CONTENT OF THE ICD WAS ANALYZED. THE AVAILABLE IEGM FROM (B)(6) 2014 AT 2:18 P.M. SHOWED INTERFERENCE SIGNALS IN ALL CHANNELS. IT WAS ALSO NOTED THAT THE BATTERY STATUS EOS WAS DETECTED ON THE SAME DAY AT 2:21 P.M. THE FREQUENCY AND MORPHOLOGY OF THE DETECTED INTERFERENCE, AS WELL AS THE EOS DETECTION ARE, WITH HIGH PROBABILITY, DUE TO THE INFLUENCE OF A STRONG EXTERNAL MAGNETIC FIELD, WHICH INDICATES THE BEGINNING OF THE DESCRIBED MAGNETIC RESONANCE IMAGING. AT THIS TIME, THE MRI MODE OF THE ICD WAS NOT ACTIVATED. THE SIGNAL SENSING OF THE ICD WAS THEN CHECKED AND PROVED TO BE FREE OF NOISE. THE ICD SENSED SUPPLIED SIGNALS FREE OF INTERFERENCE. THE EOS STATE WAS REMOVED WITH A TECHNICAL PROGRAMMER, AND THE DEVICE THEN SHOWED THE BOL STATE. THE BATTERY VOLTAGE OF 3.04 V INDICATES A CHARGED BATTERY. THE ICD'S CAPABILITY 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, IN PARTICULAR, PROVED TO BE UNREMARKABLE. THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION, THE DEVICE PROVED TO BE FULLY FUNCTIONAL. SUMMARY: THE IMPLANT PROVED TO BE WITHIN THE ELECTRICAL SPECIFICATIONS. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. IT IS VERY LIKELY THAT THE OBSERVED DEVICE BEHAVIOR WAS THE RESULT OF THE INFLUENCE OF THE STRONG EXTERNAL MAGNETIC FIELD DURING THE MAGNETIC RESONANCE IMAGING. THE MRI MODE OF THE ICR HAD NOT BEEN ACTIVATED DURING THE MRI EXAM. THERE WAS NO MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    OUS MDR - THIS DEVICE WAS FOUND TO BE EOS AFTER AN MRI WAS PERFORMED. THE IMPLANT WAS NOT PROGRAMMED TO MRI MODE BEFORE THE MRI PROCEDURE. DEVICE HAS BEEN RETURNED FOR ANALYSIS. THIS WAS ALL OF THE INFORMATION PROVIDED TO US. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96983 LUMAX 640 VR-T DX PROMRI ICD LWS BIOTRONIK SE & CO. KG 381472

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization