BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 3882075 · Received June 18, 2014

    Report

    Report Number
    2124215-2014-12600
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    April 13, 2014
    Report Date
    May 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - TS WAS INFORMED THAT THE PATIENT HAD NOW BEEN CLASSIFIED AS DNR (DO NOT RESUSCITATE). THE PATIENT SUFFERED FROM DEMENTIA AND THE FAMILY ELECTED TO HAVE NO FURTHER INVASIVE PROCEDURE PERFORMED. THE LOCAL REPRESENTATIVE CONTACTED TS 30 MINUTES LATER TO REPORT THAT THE PATIENT WAS EXHIBITING APNEIC BREATHING AND NO FURTHER INTERVENTION WAS PLANNED. DATA FROM THE MOST RECENT UPLOAD (LATE-(B)(4) 2014) WAS REVIEWED BY BOSTON SCIENTIFIC'S IN-HOUSE ENGINEERING. DATA ANALYSIS FOUND THAT THE DEVICE HAD BEEN DEPLETING NORMALLY. THE EXPECTED LIFETIME WAS SHORTENED DUE TO THE HIGH LV PACING OUTPUTS. THERE WERE NO SIGNS OF PREMATURE DEPLETION OR DEVICE MALFUNCTION. DEVICE EXPLANT AND RETURN FOR ANALYSIS WOULD BE REQUIRED IN ORDER TO DETERMINE THE CAUSE OF THE CLINICAL OBSERVATIONS. BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE PHYSICIAN SUSPECTED THAT A DEVICE MALFUNCTION HAD OCCURRED AND THAT THE COMPETITOR RV LEAD DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. THE DEVICE WAS NOT EXPLANTED POST-MORTEM AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY TESTING. THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SEVERAL CO-MORBIDITIES AND NO AUTOPSY WAS PERFORMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PHYSICIAN CONTACTED BOSTON SCIENTIFIC¿S TECHNICAL SERVICES (TS) IN MID-(B)(6) 2014. THE PHYSICIAN REPORTED THAT THIS PATIENT WAS ADMITTED INTO THE HOSPITAL WITH A HEART RATE IN THE 20 BPM RANGE. THE PHYSICIAN SUSPECTED A DEVICE OR LEAD MALFUNCTION. TS CONTACTED THE LOCAL REPRESENTATIVE TO INTERROGATE THE DEVICE. THE LOCAL REPRESENTATIVE CONTACTED TS TO REPORT THAT THE DEVICE WAS NOT PACING. THERE WERE NO MAGNET TONES GENERATED BY THE DEVICE WHEN A MAGNET WAS APPLIED OVER THE POCKET SITE. DATA FROM THE PATIENT¿S MONITORING SYSTEM WAS REVIEWED. THE LAST DATA TRANSMISSION OCCURRED IN LATE-(B)(6) 2014. THE ESTIMATED LONGEVITY TO EXPLANT WAS 4 MONTHS. THE LV OUTPUT WAS PROGRAMMED AT 6 VOLTS AT 1.7 MS. TS INSTRUCTED THE LOCAL REPRESENTATIVE TO PERFORM A ¿WAND ONLY¿ INTERROGATION THROUGH THE PG APPLICATION PATHWAY. TS WAS INFORMED THAT TELEMETRY COULD NOT BE ESTABLISHED. THE LOCAL REPRESENTATIVE MENTIONED THAT THE CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD IS A COMPETITOR PRODUCT. NO DEFIBRILLATION THRESHOLD TESTING HAD BEEN PERFORMED AT IMPLANT AND THERE HAS BEEN NO HIGH VOLTAGE SHOCKS DELIVERED. IT WAS UNKNOWN IF THE PATIENT HAD RECEIVED SHOCK THERAPY IN THE LAST COUPLE OF DAYS. THE NEXT DAY, ANOTHER LOCAL REPRESENTATIVE CONTACTED TS TO DISCUSS THIS ADVERSE EVENT. THE PATIENT HAD BEEN TRANSFERRED TO ANOTHER HOSPITAL¿S ER. THE LOCAL REPRESENTATIVE DISCUSSED THE INABILITY TO ESTABLISH TELEMETRY AND REQUESTED THAT DATA FROM THE PATIENT¿S MONITORING SYSTEM BE REVIEWED AGAIN. DATA FROM THE LAST UPLOAD (LATE-MARCH 2014) WAS REVIEWED. THE LV PACING OUTPUT HAD BEEN PROGRAMMED TO 6.0 VOLTS AT 1.7 MS WHICH MIGHT EXPLAIN THE HIGH POWER CONSUMPTION BASED ON PROGRAMMED PARAMETERS (RA 15% PACING, 70 PPM, 2.5 VOLTS, 0.4 MS PACING THRESHOLDS, 500 OHMS, RV 100% PACING, 70 PPM, 2.5 VOLTS, 0.4 MS PACING THRESHOLD, 700 OHMS, LV 100% PACING, 70 PPM, 3.5 VOLTS, 0.4 MS PACING THRESHOLDS, 700 OHMS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359272 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death| H| L 4193| 4457| H217| 4456| 4087| 7120| N119| 1290