BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 VR-T DX

    MDR report key: 8703450 · Received June 17, 2019

    Report

    Report Number
    1028232-2019-02376
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Report Date
    May 27, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P050023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ICD WAS RETURNED FOR ANALYSIS. FIRST THE MANUFACTURING PROCESS OF THIS DEVICE WAS REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE COMPLAINT. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. IN THE FIRST ANALYSIS STEP, THE ICDS 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 SPECIFICATIONS WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED, AND THE CHARGE TIME WAS AS EXPECTED. THE ICD WAS THEN SUBJECTED TO A STATUS INTERROGATION, AND THE DEVICE MEMORY WAS ANALYZED. THE ANALYSIS SHOWED THAT THE BATTERY VOLTAGE TEMPORARILY DROPPED BELOW THE ERI THRESHOLD. THIS LED TO ERI DETECTION. IN ADDITION, A DISCREPANCY WAS FOUND BETWEEN DRAWN CHARGE AND MEASURED BATTERY VOLTAGE. THE ICD WAS THEN OPENED. THE VISUAL INSPECTION OF THE INTERNAL STRUCTURE SHOWED NO IRREGULARITIES. THE POWER CONSUMPTION OF THE ELECTRONIC MODULE WAS MEASURED AND WAS AS EXPECTED. THE BATTERY WAS RETURNED TO THE MANUFACTURER FOR AN EXTENSIVE ANALYSIS. FIRST, THE PRODUCTION DOCUMENTS OF THE BATTERY WERE REVIEWED, WHICH SHOWED NO ANOMALIES. SUBSEQUENTLY, THE VOLTAGE AND THE HEAT TONE OF THE BATTERY WERE EXAMINED. DURING THE MEASUREMENT OF THE BATTERY VOLTAGE, THE BATTERY WAS STILL SUFFICIENTLY CHARGED. HOWEVER, THE PERFORMED MICROCALORIMETRIC MEASUREMENT SHOWED AN INCREASED HEAT TONE OF THE BATTERY. THE BATTERY WAS THEN OPENED, AND THE INTERNAL STRUCTURE WAS VISUALLY INSPECTED. DURING THE VISUAL INSPECTION, AN INTERNAL SHORT-CIRCUIT WAS DETECTED. THIS INTERNAL SHORT-CIRCUIT ENABLED AN INCREASED BATTERY-INTERNAL SELF-DISCHARGE. HOWEVER, BASED ON THE BATTERY STATE, A REMAINING CAPACITY FOR AT LEAST THE SPECIFIED LENGTH OF TIME FROM ERI TO EOS WAS ENSURED, IN ORDER TO BE ABLE TO GUARANTEE PROPER THERAPY FUNCTIONALITY. IN SUMMARY, THE ICD HAD BEEN IMPLANTED FOR 34 MONTHS. IN THE CONTEXT OF THE ANALYSIS, THE CLINICAL OBSERVATION RESULTED FROM THE INCREASED BATTERY-INTERNAL SELF-DISCHARGE. THE ELECTRONIC MODULE PROVED TO BE FREE OF DEFECTS DURING THE ANALYSIS. BASED ON THE ANALYSIS, ALL THERAPY FUNCTIONS CRITICAL FOR PATIENT SAFETY WERE AVAILABLE WITHOUT LIMITATIONS DURING THE IMPLANTATION TIME.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF APPROXIMATELY 34 MONTHS, IT WAS REPORTED THAT THE DEVICE WAS IN ERI. THE DEVICE WAS EXPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499527 LUMAX 540 VR-T DX ICD LWS BIOTRONIK SE & CO. KG 368852

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization