BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUMAX 340 HF-T

    MDR report key: 2943938 · Received January 31, 2013

    Report

    Report Number
    1028232-2013-00198
    Event Type
    Injury
    Date Received
    January 31, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 16, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P050023
    Adverse Event
    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 (B)(4) CHARGING CYCLES WAS DOCUMENTED. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE ANALYSIS OF THE SHOCK HOLTER SHOWED THAT AN AMOUNT OF MORE THAN 57 CHARGING CYCLES WAS PERFORMED BY THE DEVICE WITHIN 4 HOURS ON (B)(6) 2012. THE EOS STATUS OF THE DEVICE RESULTED FROM THAT SUCCESSIVE CHARGING. THE AVAILABLE IEGM'S SHOWED THAT THIS CHARGING WAS CAUSED DUE TO THE DETECTION INTRINSIC SIGNALS. 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 ICD WAS IMPLANTED FOR 61 MONTHS; 90 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 EOS BATTERY STATUS WAS ANTICIPATED.

    Description of Event or Problem · 1

    THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO ERI. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. THE HOSPITAL RETAINED THE DEVICE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED. ON (B)(6) 2013 - THIS DEVICE WAS RETURNED AND IT WAS NOTED THAT THE DEVICE IS, IN FACT, AT EOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42621 LUMAX 340 HF-T CRT-D MRM BIOTRONIK SE & CO. KG 355263

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization