BEUDAMED
    FDA Adverse Event Other Summary report: N

    LUMAX 540 HF-T

    MDR report key: 2929400 · Received January 18, 2013

    Report

    Report Number
    1028232-2013-00087
    Event Type
    Other
    Date Received
    January 18, 2013
    Report Date
    January 4, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NIK
    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 WAS INTERROGATED, REVEALING THE BATTERY STATUS MOL1. THE DEVICE WAS IMPLANTED FOR 21 MONTHS AND 590 CHARGING CYCLES WERE RECORDED TO THE DEVICE MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. THE INSPECTION REVEALED THAT THE ANTI-TACHYCARDIA THERAPY FUNCTION WAS NOT DEACTIVATED AFTER THE EXPLANTATION. AS A RESULT, NOISE WAS DETECTED AFTER THE EXPLANTATION, LEADING TO THE LARGE AMOUNT OF CHARGING CYCLES. THE HOLTER DOCUMENTS THAT THE IEGM'S BELONGING TO THE TIME WHILE THE DEVICE WAS IMPLANTED AND IN SERVICE WERE OVERWRITTEN BY THIS LARGE AMOUNT OF EPISODES DUE TO OVERSENSING AFTER THE EXPLANTATION. HOWEVER, THERE WERE NO INDICATIONS OF A DEVICE MALFUNCTION. THE ICD WAS SUBJECTED TO AN 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 DEVICE AND THE DISTAL PORTION OF THE LEADS WERE RETURNED WITH NO DOCUMENTATION. THE FOLLOWING PHYSICIAN'S OFFICE WOULD NOT RETURN PHONE CALLS. MEDTRONIC, BOSTON SCIENTIFIC AND ST JUDE MEDICAL HAVE NO RECORD OF THIS PT. THERE IS NO INFO INDICATING THAT THIS PT HAS EXPIRED. THE DATE AND REASON FOR EXPLANT ARE UNK. NO COMPLAINTS OR ADVERSE EVENTS HAVE BEEN REPORTED TO BIOTRONIK. SHOULD ADD'L INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27586 LUMAX 540 HF-T CRT-D NIK BIOTRONIK SE & CO. KG 360347

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization