BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 VR-T

    MDR report key: 3962016 · Received July 28, 2014

    Report

    Report Number
    1028232-2014-002615
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    February 20, 2014
    Report Date
    July 18, 2014
    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 EOS. THE DEVICE WAS IMPLANTED FOR 44 MONTHS AND A LARGE AMOUNT OF 89 CHARGING CYCLES WAS RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE ANALYSIS OF THE SHOCK HOLTER SHOWED THAT AN AMOUNT OF 66 CHARGING CYCLES, OF WHICH 55 RESULTED IN SHOCK DELIVERIES, WAS PERFORMED BY THE DEVICE ON (B)(6) 2014. THE EOS STATUS OF THE DEVICE RESULTED FROM THAT SUCCESSIVE CHARGING. THE AVAILABLE IEGMS SHOWED THAT THIS CHARGING WAS CAUSED DUE TO THE DETECTION OF NOISE IN THE RIGHT VENTRICULAR AS WELL AS THE FAR-FIELD CHANNEL. THEREFORE A SENSING TEST WAS PERFORMED AND THE DEVICE SENSED THE ATTACHED HEART SIGNALS FREE OF NOISE, PROVING THE SENSING FUNCTION OF THE ICD TO BE FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. NEXT, THE DEVICE WAS SUBJECTED TO AN ELECTRICAL ANALYSIS. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND SUBSEQUENT INTERROGATION SHOWED THE BATTERY STATUS ERI. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTITACHYCARDIA 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. IN SUMMARY, THE DEVICE STATUS EOS RESULTED FROM SUCCESSIVE CHARGING DUE TO THE DETECTION OF NOISE. HOWEVER, THE ICD PROVED TO BE FULLY FUNCTIONAL DURING ANALYSIS. TAKING THE LARGE AMOUNT OF 89 CHARGING CYCLES INTO ACCOUNT, THE BATTERY STATUS WAS ANTICIPATED. THERE WAS NO INDICATION FOR A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - PATIENT RECEIVED MULTIPLE SHOCKS, NOISE FROM LEAD IS SUSPECTED TO BE THE REASON FOR SOME OF THEM. THE NOISE WAS REPRODUCED WITH THE DEVICE INTERROGATED, WHEN THE PATIENT MOVED HIS LEFT ARM OVER HIS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437770 LUMAX 340 VR-T ICD LWS BIOTRONIK SE & CO. KG 355271

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization