BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 300 HF-T

    MDR report key: 2140362 · Received June 17, 2011

    Report

    Report Number
    1028232-2011-01338
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    PMA / PMN Number
    P050023
    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 INTERROGATION REVEALED THE BATTERY STATUS EOS. A NUMBER OF 25 CHARGING CYCLES WAS DOCUMENTED. THE EOS STATUS WAS REMOVED WITH A TECHNICAL PROGRAMMER AND 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 MEMORY CONTENT OF THE DEVICE WAS INSPECTED. IT WAS NOTED THAT THE LEFT VENTRICULAR ANTI-BRADYCARDIA PACING WAS PROGRAMMED TO 4.5 V @ 1.5 MS. THIS REPRESENTS A HIGH CURRENT PROGRAM IMPLYING FASTER DISCHARGING OF THE BATTERY. IN SUMMARY, THE ICD WAS IMPLANTED FOR 47 MONTHS; 25 CHARGING CYCLES WERE DOCUMENTED IN THE ICD'S MEMORY. THE AMOUNT OF CHARGE TAKEN FROM THE BATTERY WAS VERIFIED. THE BATTERY CONDITION WAS FOUND TO BE AS ANTICIPATED. THE ICD WAS FULLY FUNCTIONAL. THE EOS BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THIS DEVICE IS AT EOS INDICATION AND WAS EXPLANTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    (B)(6) 2013 - THIS DEVICE WAS RETURNED TO (B)(4) AND THEN RETURNED TO (B)(4) ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMAX 300 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 355262

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization