BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 HF-T

    MDR report key: 3053646 · Received April 11, 2013

    Report

    Report Number
    1028232-2013-00938
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    March 28, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS EOS. THE DEVICE WAS IMPLANTED FOR 32 MONTHS AND 22 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED, REVEALING NO ANOMALIES. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE. FURTHERMORE THE INSPECTION REVEALED THAT THE EOS STATUS WAS TRIGGERED BY THE DEVICE 18 DAYS AFTER IT HAD BEEN EXPLANTED, RESULTING FROM AN AUTOMATIC CAPACITOR REFORMATION MOST LIKELY IN A COLD TEMPERATURE ENVIRONMENT. THE DEVICE WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION REVEALED THE BATTERY STATUS ERI. 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. IN SUMMARY, THE DEVICE PROVED TO BE FULLY FUNCTIONAL DURING ANALYSIS. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM. THE ICD WAS IMPLANTED FOR 32 MONTHS; 22 CHARGING CYCLES WERE DOCUMENTED IN THE ICD¿S MEMORY. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION OF ERI WAS FOUND TO BE ANTICIPATED. THE EOS STATUS WAS TRIGGERED 18 DAYS AFTER THE EXPLANT OF THE DEVICE DUE TO INFLUENCES OF A COLD TEMPERATURE ENVIRONMENT.

    Additional Manufacturer Narrative · 1

    (B)(4) 2014- WE WERE NOTIFIED THAT WE WERE PROVIDED WITH THE WRONG EVALUATION AND EVALUATION CODES. THE CORRECT EVALUATION IS: UPON RECEIPT, THE DEVICE INTERROGATION REVEALED THE BATTERY STATUS ERI. A NUMBER OF 14 CHARGING CYCLES WAS DOCUMENTED. 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. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED AND AN ELEVATED CURRENT CONSUMPTION WAS NOTICED. THEREFORE, THE ICD WAS OPENED AND THE INNER ASSEMBLY WAS INSPECTED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. FURTHER ELECTRICAL INVESTIGATIONS REVEALED THAT AN INTEGRATED CIRCUIT ON THE ELECTRONIC MODULE WAS DAMAGED, CAUSING AN INCREASED CURRENT CONSUMPTION, DRAINING THE BATTERY. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. PARTICULARLY THE FINAL ACCEPTANCE TEST PROVED THE DEVICE FUNCTIONS TO BE FLAWLESS. IN SUMMARY, THE CLINICAL OBSERVATION RESULTED FROM A DAMAGED INTEGRATED CIRCUIT ON THE ELECTRONIC MODULE. THE MANUFACTURING RECORDS DOCUMENT A FLAWLESS DEVICE PRODUCTION. IT IS THEREFORE ASSUMED, THAT THE DAMAGE OCCURRED AFTER THE DEVICE SHIPMENT, HOWEVER. THE DATE OF OCCURRENCE WAS NOT DETERMINABLE.

    Description of Event or Problem · 1

    THIS DEVICE IS AT ERI INDICATION AND WAS REPLACED WITH ANOTHER CRT-D. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156035 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization