BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 DR-T

    MDR report key: 2903947 · Received November 29, 2012

    Report

    Report Number
    1028232-2012-03014
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    August 23, 2012
    Report Date
    November 16, 2012
    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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS BOL. THE DEVICE WAS IMPLANTED FOR ONE DAY AND ONE CHARGING CYCLE WAS RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED, NO IEGM WAS RECORDED TO THE DEVICE'S MEMORY. THE INSPECTION REVEALED THAT A PACING IMPEDANCE OF "1610 OHMS" WAS MEASURED IN THE RIGHT VENTRICULAR CHANNEL ON (B)(6) 2012, ONE DAY AFTER THE REPORTED IMPLANTATION. NO FURTHER IMPEDANCE MEASUREMENTS WERE DOCUMENTED IN THE DEVICE'S MEMORY. 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. DURING FURTHER ANALYSIS, THE IMPEDANCE MEASUREMENT FUNCTIONS OF THE DEVICE WERE TESTED USING DIFFERENT TEMPERATURE ENVIRONMENTS. HOWEVER, THE IMPEDANCE MEASUREMENT FUNCTIONS PROVED TO BE FLAWLESS. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - AT IMPLANT, THE LEADS TESTED FINE. THERE WERE GOOD R+ P-WAVE, THRESHOLDS, AND IMPEDANCES. THEY WERE THEN CONNECTED TO THE DEVICE AND WHEN DOING DFT, THE PT WAS SHOCKED INTO AF WHICH REQUIRED USE OF AN EXTERNAL DEVICE TO SHOCK BACK INTO NORMAL SINUS RHYTHM. THE NEXT MORNING, V IMP>3000, AN IMP 1447 OHMS, SHOCK IMP 43 OHMS, P WAVE 1.7 MV, R-WAVE 7.8 MV. THE LEADS THEMSELVES TESTED FINE, BUT ONCE THEY WERE CONNECTED TO THE DEVICE AGAIN, UNACCEPTABLE READINGS WERE NOTED. A NEW DEVICE WAS CONNECTED AND EVERYTHING TESTED OUT JUST FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 340 DR-T ICD MRM BIOTRONIK SE & CO. KG 355267

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization