BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIENT

    MDR report key: 1850214 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-13848
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 4, 2010
    Report Date
    December 2, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ATTEMPT HAS BEEN MADE TO GATHER ADDITIONAL INFORMATION ABOUT THIS EVENT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PHYSICIAN BELIEVED THE DEVICE WORKED APPROPRIATELY AS PROGRAMMED, AND THAT THE PATIENT'S SYNCOPE AND SEPSIS WERE NOT RELATED TO THE DEVICE. AVAILABLE INFORMATION SUGGESTS THAT THIS PATIENT REMAINS ON A VENTILATOR AT THIS TIME. THE DEVICE WAS REPROGRAMMED FROM DDI 40 TO DDD 60, SINCE DEVICE TRENDING DATA SHOWED THE PATIENT'S HEART RATE DROPPING INTO THE 40 BPM RANGE DURING THE TIME HE PASSED OUT. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING, AND SENSING FUNCTIONS WERE TESTED. IMPEDANCE TESTING WAS COMPLETED AND ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT WAS FOUND BY HIS WIFE TO BE UNCONSCIOUS ON THE FLOOR. WHEN MEDICAL PERSONNEL ARRIVED, HIS HEART RATE WAS REPORTEDLY IN THE 40 BPM RANGE. NO EPISODES COINCIDING WITH THESE EVENTS WERE STORED IN DEVICE MEMORY; HOWEVER, TRENDING DATA WITHIN DEVICE MEMORY SHOWED A SUDDEN DROP IN HEART RATE. THE PATIENT IS NOW REPORTEDLY ON A VENTILATOR, AND IS DEALING WITH SEPSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    APPROXIMATELY SEVEN YEARS LATER THIS DEVICE WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIENT IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E030

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R E030| 0185| 4136