BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMAX 540 DR-T

    MDR report key: 2973618 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00276
    Event Type
    Death
    Date Received
    February 13, 2013
    Date of Event
    September 28, 2012
    Report Date
    January 29, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    MRM
    PMA / PMN Number
    P000009
    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 ICD WAS INTERROGATED, REVEALING THE BATTERY STATUS EOS. THE ICD WAS IMPLANTED FOR 30 MONTHS AND 196 CHARGING CYCLES WERE RECORDED TO THE ICD'S MEMORY. THE MEMORY CONTENT OF THE DEVICE WAS INSPECTED. DURING THE ANALYSIS OF THE AVAILABLE IEGM'S NOISE WAS OBSERVED IN THE VENTRICULAR CHANNEL. THE ANALYSIS OF THE SHOCK HOLTER SHOWED THAT AN AMOUNT OF MORE THAN 127 CHARGING CYCLES WAS PERFORMED BY THE DEVICE WITHIN 2 DAYS ON (B)(6) 2012. THE EOS STATUS OF THE DEVICE RESULTED FROM THAT EXCESSIVE CHARGING. 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. 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 DELIVERED A DEFIBRILLATION SHOCK AS SPECIFIED, DOCUMENTING A CORRECT SENSING AND SHOCK DELIVERY. IN PARTICULAR, THE SPECIFIED ENERGY LEVEL WAS REACHED. IN SUMMARY, THE ICD IS PROVED TO FULLY FUNCTIONAL. THERE WAS NO INDICATION OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS DEVICE WAS RETURNED WITHOUT OOS DOCUMENTATION. THIS DEVICE IS EOS AND THERE WAS NOISE ON THE RV CHANNEL. PER ONLINE DEATH NOTIFICATION, THIS PT EXPIRED ON (B)(6) 2012 WHILE UNDER MEDICAL CARE OF AN UNSPECIFIED ILLNESS. THE FOLLOWING AND IMPLANTING PHYSICIANS' OFFICES HAVE NOT SEEN THIS PT SINCE 2010. THE CAUSE OF DEATH IS UNK. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64316 LUMAX 540 DR-T ICD MRM BIOTRONIK SE & CO. KG 360346

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death