BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 HF-T

    MDR report key: 5211002 · Received November 9, 2015

    Report

    Report Number
    1028232-2015-04030
    Event Type
    Death
    Date Received
    November 9, 2015
    Date of Event
    October 4, 2015
    Report Date
    October 27, 2015
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE NORMAL AND 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. IN CONCLUSION, THE DELAYED TRANSMISSION OF THE VF EPISODE AS WELL AS THE NOTIFICATION OF BOTH VF EVENTS COULD BE CONFIRMED. HOWEVER, BASED ON THE AVAILABLE DATA THE ROOT CAUSE OF THE CLINICAL OBSERVATION WAS NOT DETERMINABLE. THE FUNCTIONALITY OF THE DEVICE WAS THOROUGHLY TESTED. THE ICD WAS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    (B)(4) - A HOME MONITORING ALERT WAS RECEIVED ON (B)(6) NOTING A VF EVENT. THE PHYSICIAN LOGGED IN TO CONFIRM THE VF EVENT, BUT THE ALERT HAD NOT ARRIVED. THE PHYSICIAN CALLED THE PATIENT, BUT WAS UNABLE TO CONTACT HIM. AFTER THIS EVENT, NO OTHER DATA HAD ARRIVED UNTIL THE MORNING OF (B)(6), INCLUDING THE PERIODIC IEGM FROM THE 5TH. THE VF RECORD SHOWED ONE SHOCK THERAPY WAS DELIVERED IN THE MORNING OF (B)(6) AND IT WAS ONLY ONE MINUTE AFTER THE VT EVENT. THE PHYSICIAN REQUESTED TO VISIT THE PATIENT AT HOME THROUGH A CASEWORKER; ON (B)(6) IT WAS CONFIRMED THE PATIENT HAD DIED. IT IS BELIEVED THE DELAY IN THE VF ALERT MIGHT HAVE BEEN DUE TO SOMETHING IN THE HOME INTERFERING WITH THE TRANSMISSION OR SOME TYPE OF OBSTACLE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740935 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 Death