BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 VR-T

    MDR report key: 3252059 · Received July 29, 2013

    Report

    Report Number
    1028232-2013-02082
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    April 17, 2013
    Report Date
    July 18, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL1. THE DEVICE WAS IMPLANTED FOR 38 MONTHS AND 22 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED AND A DISCREPANCY BETWEEN BATTERY VOLTAGE AND ELECTRICAL CHARGE USED BY THE DEVICE WAS NOTICED, INDICATING A DEPLETED BATTERY. THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. 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. DUE TO THE DROP OF THE BATTERY VOLTAGE BELOW THE ERI THRESHOLD, THE BATTERY STATUS OF ERI WAS ACTIVATED. THE ICD WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. THE BATTERY WAS FOUND TO BE DEPLETED. THE ELECTRONIC MODULE WAS ATTACHED TO AN EXTERNAL POWER SUPPLY. THE ELECTRICAL PARAMETERS, PARTICULARLY THE CURRENT CONSUMPTION OF THE ELECTRONIC MODULE WERE FOUND TO BE WITHIN SPECIFICATION WITH AN EXTERNAL POWER SUPPLY ATTACHED. THE ABILITY OF THE ELECTRONIC MODULE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA PACING PULSES PROVED TO BE FLAWLESS 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. THE BATTERY WAS SENT TO THE MANUFACTURER FOR FURTHER ANALYSIS. ANALYSIS OF THE BATTERY: THE MANUFACTURING RECORDS WERE INSPECTED, DOCUMENTING THAT THE BATTERY PARAMETERS WERE WITHIN SPECIFICATION DURING THE BATTERY MANUFACTURING. NO ANOMALIES WERE DOCUMENTED DURING THE PRODUCTION PROCESS, ASSOCIATED TO THIS BATTERY. THE VISUAL INSPECTION OF THE BATTERY DID NOT REVEAL ANY EXTERNAL SIGNS OF DAMAGE. THE VOLTAGE MEASUREMENT CONFIRMED THE BATTERY DEPLETION. AT A NEXT STEP, THE BATTERY WAS OPENED FOR DESTRUCTIVE ANALYSIS. DURING THE INSPECTION OF THE INNER ASSEMBLY AN INSULATION DAMAGE WAS IDENTIFIED, WHICH LED TO AN INCREASED INTERNAL SELF-DEPLETION WITHIN THE BATTERY AND THEREFORE TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS IMPLANTED FOR 38 MONTHS. THE ICD WAS ELECTIVELY EXPLANTED BASED ON THE FINDINGS IN THE HOME MONITORING DEVICE DATA. AN INCREASED INTERNAL SELF-DEPLETION WITHIN THE BATTERY CONTRIBUTED TO AN ACCELERATED BATTERY DEPLETION. THE DEVICE WAS FULLY FUNCTIONAL WHILE IT WAS IMPLANTED AND IN SERVICE. ESPECIALLY ALL THERAPY FUNCTIONS OF THE ICD WERE AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - VIA HOME MONITORING AN EXCESSIVE CURRENT CONSUMPTION WAS REPORTED. THE DEVICE HAD BEEN IMPLANTED FOR ABOUT 38 MONTHS. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353852 LUMAX 540 VR-T ICD LWS BIOTRONIK SE & CO. KG 360348

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization