BEUDAMED
    FDA Adverse Event Death Summary report: N

    INOGEN

    MDR report key: 6046713 · Received October 21, 2016

    Report

    Report Number
    2124215-2016-17480
    Event Type
    Death
    Date Received
    October 21, 2016
    Date of Event
    July 22, 2016
    Report Date
    November 14, 2016
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD IS EXPECTED TO BE RETURNED. ONCE THE PRODUCT IS RECEIVED AND ANALYSIS COMPLETED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY ANALYZED. THE DEVICE WAS UNABLE TO BE INTERROGATED UPON RECEIPT; THUS, A MEMORY DOWNLOAD WAS UNABLE TO BE PERFORMED FOR REVIEW. VISUAL INSPECTION OF THE DEVICE CASE AND HEADER NOTED TOOL MARKS AS WELL AS AN ARC MARK ON THE BOTTOM FRONT EDGE OF THE CASE. ALL SEAL PLUGS WERE INTACT AND THE SETSCREWS MOVED FREELY. AN X-RAY OF THE DEVICE REVEALED THAT THE INTERNAL HIGH VOLTAGE FUSE WAS DAMAGED (I.E., NO LONGER INTACT). THE DEVICE CASE WAS OPENED. NO ANOMALIES WERE NOTED UPON TESTING OF THE INTERNAL COMPONENTS. NO FURTHER ANALYSIS COULD BE PERFORMED. THE LEAD WAS RETURNED STILL CONNECTED TO THE DEVICE. VISUAL INSPECTION NOTED THAT THE LEAD WAS SEVERED APPROXIMATELY 29 CENTIMETERS FROM THE TERMINAL PIN. THERE ARE SIGNS OF ARCING DAMAGE ON THE SEVERED END OF THE LEAD. LABORATORY ANALYSIS DETERMINED THAT THE ARCING DAMAGE OCCURRED AFTER THE SYSTEM WAS EXPLANTED POST MORTEM AND WAS CAUSED BY THE DEVICE NOT BEING DEACTIVATED PRIOR TO REMOVAL. LABORATORY ANALYSIS COULD NOT CONFIRM THE OTHER CLINICAL OBSERVATIONS AS A MEMORY DOWNLOAD COULD NOT BE PERFORMED UPON RECEIPT AND NO FURTHER ANALYSIS COULD BE PERFORMED DUE TO THE INDUCED DAMAGE SUSTAINED TO THE DEVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVELOPED A FEVER. LATER THE SAME DAY, THE PATIENT WAS FOUND UNRESPONSIVE. ATTEMPTS TO REVIVE THE PATIENT FAILED AND THE PATIENT WAS PRONOUNCED DEAD. THE CAUSE OF DEATH WAS CARDIOPULMONARY ARREST. AT THE TIME, THERE WERE NO ALLEGATIONS AGAINST THE FUNCTIONALITY OR THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH AT THE TIME. AT A LATER DATE, THE HOSPITAL NOTIFIED BOSTON SCIENTIFIC THAT THE PHYSICIAN CLAIMED THAT THE DEVICE FAILED TO SHOCK WHEN THE PATIENT WAS IN A VENTRICULAR FIBRILLATION (VF), WHICH CONTRIBUTED TO THE PATIENT'S DEATH. NO MEMORY DOWNLOAD WAS PERFORMED ON THE ICD WHEN IT WAS RECEIVED POST-MORTEM AS THERE WERE NO ALLEGATIONS. CURRENTLY, THE ICD IS NOT ABLE TO BE INTERROGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699541 INOGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND D141

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death 0180| 1860| D141