BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INLEXA 3 VR-T DF-1

    MDR report key: 10649615 · Received October 8, 2020

    Report

    Report Number
    1028232-2020-04328
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 25, 2020
    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

    PRIOR TO THE ANALYSIS OF THE DEVICE, THE QUALITY DOCUMENTS ACCOMPANYING THE MANUFACTURING PROCESS OF THIS ICD WERE REVIEWED. THE PRODUCTION DOCUMENTS SHOWED NO ANOMALIES. ALL MANUFACTURING STEPS HAD BEEN CARRIED OUT CORRECTLY. A PERFORMED STANDARD FINAL ELECTRICAL TEST DOCUMENTED PROPER DEVICE BEHAVIOR. THE ICD UNDERWENT A STATUS INTERROGATION, AND THE DEVICE MEMORY WAS ANALYZED. THE DEVICE STATUS WAS ERI, 12 CHARGE PROCESSES HAD BEEN DOCUMENTED. THE CHARGE DRAWN FROM THE BATTERY WAS CHECKED. THE CHECK INDICATED THAT THE DISCHARGE OF THE BATTERY WAS NOT AS EXPECTED. THE CURRENT UPTAKE OF THE DEVICE WAS THEN EXAMINED, WHICH PROVED TO BE INCONSPICUOUS. AN ADDITIONALLY PERFORMED LONG-TERM STUDY OF THE CURRENT UPTAKE ALSO SHOWED NO ANOMALIES. THE ICDS CAPABILITY TO PROVIDE THERAPY WAS REVIEWED. 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 OPENED. THE VISUAL INSPECTION OF THE INTERNAL STRUCTURE SHOWED NO IRREGULARITIES. THE BATTERY VOLTAGE WAS MEASURED. THE MEASUREMENT CONFIRMED THAT THE BATTERY DISCHARGE WAS NOT AS EXPECTED. THE BATTERY WAS RETURNED TO THE MANUFACTURER OF THE BATTERY FOR AN EXTENSIVE ANALYSIS. THE PRODUCTION DOCUMENTS OF THE BATTERY WERE REVIEWED AND PROVED THAT THERE WAS NO DEVIATION OF THE BATTERY PARAMETERS FROM THE SPECIFIED VALUES DURING THE MANUFACTURING PROCESS. THE BATTERY WAS OPENED AND VISUALLY INSPECTED. DURING THE VISUAL INSPECTION, THE LITHIUM PLATING PHENOMENON WAS DETECTED. THIS ENABLED AN INCREASED BATTERY-INTERNAL SELF-DISCHARGE, WHICH CONTRIBUTED TO A PREMATURE BATTERY DEPLETION. PLEASE NOTE THAT THIS ICD IS AFFECTED BY A CORRECTIVE MEASURE, BIO-LOQ, THAT WAS INITIATED IN MARCH 2021.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION PERIOD OF APPROX. 28 MONTHS, IT WAS REPORTED THAT THE DEVICE SHOWS THE ERI STATUS. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118181 INLEXA 3 VR-T DF-1 ICD LWS BIOTRONIK SE & CO. KG 404703

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization