BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 740 VR-T

    MDR report key: 3082839 · Received April 29, 2013

    Report

    Report Number
    1028232-2013-01118
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS INTERROGATED, REVEALING THE BATTERY STATUS BOL. THE DEVICE WAS IMPLANTED FOR 1 DAY AND 1 CHARGING CYCLE WAS RECORDED TO THE DEVICE MEMORY. THE INSPECTION OF THE ICD MEMORY REVEALED A PACING IMPEDANCE OF 200 OHMS IN THE RIGHT VENTRICULAR CHANNEL, CONFIRMING THE CLINICAL OBSERVATION MENTIONED IN THE COMPLAINT DESCRIPTION. THEREFORE, THE IMPEDANCE MEASUREMENT FUNCTIONS OF THE DEVICE WERE TESTED UNDER IN VIVO CONDITIONS. HOWEVER, THE IMPEDANCE MEASUREMENT FUNCTIONS PROVED TO BE FLAWLESS. THE ICD WAS SUBJECTED TO A FURTHER 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. IN SUMMARY, THE DEVICE IS FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THE PHYSICIAN REQUESTED A NEW DEVICE AFTER MULTIPLE OUT OF RANGE IMPEDANCE MEASURES AND EXPLANTED THIS DEVICE ONE DAY POST IMPLANT AND CAPPED THE RV LEAD DUE TO LOW IMPEDANCES AND ELEVATED THRESHOLDS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185616 LUMAX 740 VR-T ICD LWS BIOTRONIK SE & CO. KG 365609

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization