BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUMOS VR-T

    MDR report key: 1661289 · Received April 13, 2010

    Report

    Report Number
    1028232-2010-00659
    Event Type
    Death
    Date Received
    April 13, 2010
    Date of Event
    August 25, 2009
    Report Date
    March 9, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL ANALYSIS SHOWED THAT THE ICD COULD BE INTERROGATED. THE MEMORY CONTENTS INDICATED AN ICD RESPONSE ACCORDING TO SPECIFICATIONS. THERE WERE NO INDICATIONS OF A DEVICE FAILURE. THE ICD FIRST UNDERWENT A STATUS INTERROGATION. THE DEVICE STATUS WAS EOS, 132 CHARGE PROCESSES HAD BEEN DOCUMENTED. AS PART OF THE ELECTRICAL ANALYSIS, THE MEMORY CONTENT OF THE ICD WAS STUDIED FIRST. THE ANALYSIS OF THE EXISTING IEGMS SHOWED THAT SOLELY INTRINSIC SIGNALS HAD LED TO THE 132 CHARGE PROCESSES, A PART OF THEM ABORTED. THE ANALYSIS ALSO SHOWED THAT 124 CHARGE PROCESSES WERE CARRIED OUT WITHIN A TIME PERIOD OF 1.5 HOURS. THIS EXCESSIVE CHARGING OF THE SHOCK CAPACITORS LED TO A TEMPORARY DECREASE OF THE BATTERY VOLTAGE DUE TO THE CONSIDERABLE BURDEN ON THE BATTERY AND THUS TO THE DETECTION OF EOS. THERE WERE NO INDICATIONS OF A DEVICE DYSFUNCTION. THE EOS STATE WAS REMOVED WITH A TECHNICAL PROGRAMMER, AND THE DEVICE THEN SHOWED THE STATE MOL2. THE ICD'S ABILITY TO PROVIDE THERAPY WAS TESTED. THE ANTIBRADYCARDIC OUTPUT SIGNAL WAS NORMAL AND MATCHED THE PROGRAMMED VALUES. A FIBRILLATION SIGNAL WAS FED IN, AND THE DEVICES REACTED ACCORDING TO SPECIFICATION WITH A DEFIBRILLATION SHOCK. THE SPECIFIED ENERGY LEVEL WAS REACHED. THE CHARGE TIME WAS UNREMARKABLE. A CHECK OF THE INTERROGABILITY OF THE DEVICE AND OF THE SIGNAL SENSING SHOWED NO ANOMALIES THAT COULD BE RELATED TO THE CLINICAL OBSERVATIONS. THE DEVICE FUNCTIONED IN CONFORMITY WITH THE SPECIFICATIONS. THE ANALYSIS OF THE ICD DID NOT INDICATE A MATERIAL DEFECT OR MANUFACTURING ERROR.

    Description of Event or Problem · 1

    AFTER AN IMPLANTATION TIME OF ABOUT 5 MONTHS, THE PATIENT ARRIVED AT THE FOLLOW-UP WITH EPISODES OF VT AND SHOCK. THE DEVICE HAD WORKED WITHOUT PROBLEMS. AN INCREASE IN PACING THRESHOLD WAS NOTED AND THE PATIENT WAS SUPPOSED TO COME TO THE NEXT FOLLOW-UP IN 4 WEEKS, IN ORDER TO CONTROL THE PACING THRESHOLD INCREASE. ON (B) (6) 2009, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM CLOSE TO DEATH AND DIED. THE ICD COULD NOT BE INTERROGATED. LINOX SD 65/18, (B) (4) 1028232-2010-00660.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMOS VR-T ICD LWS BIOTRONIK SE & CO. KG 353219

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death