BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1677983 · Received May 6, 2010

    Report

    Report Number
    2124215-2010-10317
    Event Type
    Death
    Date Received
    May 6, 2010
    Date of Event
    April 9, 2010
    Report Date
    April 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR REVIEW OF THE STORED DATA DOWNLOADED FROM THE DEVICE SHOWED THERE WERE 28 EPISODES REGISTERED OVER A 57-MINS PERIOD APPROX SIX HOURS BEFORE THE REPORTED TIME OF DEATH, WITH A TOTAL OF FIVE HIGH-VOLTAGE SHOCKS AND SEVEN ANTI-TACHYCARDIA PACING BURSTS DELIVERED IN THAT PERIOD. OVERALL, THERE WERE SHORT PERIODS OF UNDERSENSING SEEN WITH HIGH-VOLTAGE SHOCKS DELIVERED INTO WHAT APPEARED TO BE INCESSANT VENTRICULAR FIBRILLATION (VF). THERE WERE ALSO LONG PERIODS WHERE THE RIGHT VENTRICULAR AND SHOCK ELECTROGRAMS SEEMED TO OCCUR AT DIFFERING INTERVALS, PROBABLY RELATED TO ENTRANCE BLOCK OR PARASYSTOLIC ACTIVITY. THE DELIVERED SHOCKS CONVERTED THE VF INTO ASYSTOLE AND AV (ATRIO-VENTRICULAR) PACED BEATS. THESE CONVERSIONS WERE OF SHORT DURATION, HOWEVER, THE VF APPEARED TO RETURN AFTER ONLY A FEW SECONDS. THERAPY DELIVERY WAS COMPLICATED BY THE DEVICE'S VT-1 ZONE PROGRAMMING (MONITOR ONLY) AND THE INTERMITTENT VENTRICULAR SENSING FOR THE ABOVE-NOTED ISSUES. OUR POST MARKET QUALITY ASSURANCE LABORATORY ANALYSIS OF THE RETURNED DEVICE IS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFO FROM A BOSTON SCIENTIFIC FIELD REP THAT THIS CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) WAS ASSOCIATED WITH A REPORT OF THE PT'S DEATH, AND SUBSEQUENT DEVICE INTERROGATION SHOWED POSSIBLE VENTRICULAR UNDERSENSING. NO ADDITIONAL INFO WAS IMMEDIATELY AVAILABLE FROM THE PT'S PHYSICIAN OR FUNERAL HOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death 4135| 4555| 0184| 4136