BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 340 HF-T

    MDR report key: 4211034 · Received October 29, 2014

    Report

    Report Number
    1028232-2014-003763
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 13, 2014
    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 ERI. A NUMBER OF 27 CHARGING CYCLES WAS DOCUMENTED. THE ABILITY OF THE DEVICE TO DELIVER THERAPIES WAS VERIFIED. THE ANTI-BRADYCARDIA 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. THE ICD WAS IMPLANTED FOR 42 MONTHS; TWENTY SEVEN 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 ANTICIPATED. IN SUMMARY, THE ICD WAS FULLY FUNCTIONAL. THE ERI BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THIS DEVICE WAS AT ERI INDICATION AND WAS REPLACED WITH A NEW CRT-D. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692466 LUMAX 340 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 355263

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization