BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540 DR-T

    MDR report key: 3100763 · Received May 8, 2013

    Report

    Report Number
    1028232-2013-01316
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    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 ERI. THE DEVICE WAS IMPLANTED FOR 20 MONTHS. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. IT WAS NOTED THAT THE EOS BATTERY STATUS WAS ACTIVATED ON (B)(6) 2013, AND A DEVICE RESET WAS PERFORMED ON (B)(6) 2013, ACTIVATING THE ERI BATTERY STATUS. THE ANALYSIS OF THE AVAILABLE IEGM'S SHOWED A NORMAL DEVICE BEHAVIOR WITH ADEQUATE TACHYCARDIA DETECTION AND THERAPY. THE DEVICE 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 DETECTED THE FIBRILLATION SIGNAL AS SPECIFIED AND STARTED THE CHARGING OF A DEFIBRILLATION SHOCK, HOWEVER, THE CHARGING WAS ABORTED, INDICATING A DEPLETED BATTERY. THE ICD WAS OPENED. THE VISUAL INSPECTION OF THE INNER ASSEMBLY SHOWED NO ANOMALIES. THE CURRENT CONSUMPTION OF THE ELECTRONIC MODULE WAS WITHIN SPECIFICATION. THE ELECTRONIC MODULE WAS ATTACHED TO AN EXTERNAL POWER SUPPLY. ONCE AGAIN 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. 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 ELECTRICAL MEASUREMENT CONFIRMED THE BATTERY DEPLETION. THE DESTRUCTIVE ANALYSIS OF THE BATTERY YIELDED NO ANOMALIES. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE ANTICIPATED. THERE WAS NO INDICATION OF A WORKMANSHIP PROBLEM OR A MATERIAL DEFECT. IN SUMMARY, WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. DESPITE THOROUGH AND TIME CONSUMING ANALYSIS NO CONCLUSION COULD BE DRAWN REGARDING THE ROOT CAUSE OF THE CLINICAL OBSERVATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE DEVICE DISPLAYS EOS WARNING WITH LOW BATTERY VOLTAGE. A DEVICE RESET WAS UNSUCCESSFUL AND EXPLANT OF THE DEVICE WAS RECOMMENDED. (B)(6) 2013 - THIS DEVICE WAS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201027 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization