BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3932231 · Received July 14, 2014

    Report

    Report Number
    1028232-2014-002389
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT THE ICD WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THEREBY THE CLINICAL OBSERVATION WAS CONFIRMED, THE DEVICE WAS NOT INTERROGATABLE. THE DEVICE HISTORY RECORD WAS INSPECTED, DOCUMENTING THAT THE DEVICE PERFORMED AS EXPECTED DURING THE DEVICE MANUFACTURING. 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 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. NEXT, 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 55 MONTHS. THE CLINICAL OBSERVATION RESULTED FROM AN INTERNAL SELF-DEPLETION WITHIN THE BATTERY.

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 56 MONTHS, IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED DURING A ROUTINE FOLLOW-UP. THE PATIENT WAS ADMITTED TO HOSPITAL AND THE DEVICE WAS REPLACED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410963 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization