BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2781133 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13071
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 1, 2012
    Report Date
    September 26, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED. BRENYO, ANDREW J., AKTAS, MEHMET K. POST IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR SYNCOPE: WHAT IS THE MECHANISM?, INNOVATIONS IN CARDIAC RHYTHM MANAGEMENT, SEPTEMBER 2012, 3 (2012), P. 931-934.

    Description of Event or Problem · 1

    JOURNAL ARTICLE OF A CASE STUDY INVOLVING A (B)(6) MAN, IMPLANTED WITH A COGNIS N118 DEVICE, WHO WAS ADMITTED TO THE HOSPITAL WITH DECOMPENSATED HF AND ELECTRICAL VT STORM. DESPITE OPTIMAL MEDICAL THERAPY AND DUAL ANTIARRHYTHMIC DRUG THERAPY, THE PATIENT CONTINUED TO HAVE INCESSANT VT REQUIRING ICD SHOCKS. THE PATIENT UNDERWENT SEVERAL VT RFAS, BUT CONTINUED TO EXPERIENCE FREQUENT VT EPSIODES. DURING ONE EPSIODE OF SUSTAINED VT THAT REQUIRED ATP AND SHOCK THERAPY, THE PATIENT WAS FOUND TO HAVE LOSS OF VENTRICULAR PACING POST-SHOCK RESULTING IN A VENTRICULAR ESCAPE BEAT AT 25 BPM AND SYNCOPE. APPROXIMATELY 3.5 MINUTES LATER, RESUMPTION OF VENTRICULAR PACING WAS IDENTIFIED. ALL LEAD DIAGNOSTIC MEASUREMENTS WERE NORMAL AND HAD REMAINED UNCHANGED FROM THE PRIOR DEVICE INTERROGATION. DURING THE POST-SHOCK PERIOD, THE DEVICE AUTOMATICALLY EXTENDS THE 'RV-BLANK AFTER A-PACE' TIME TO 85MS. AFTER THE PROGRAMMED POST-SHOCK PACING DURATION EXPIRES AND NORMAL BRADYCARDIA PACING RESUMES, SMART BLANKING SHORTENS THE 'RV-BLANK AFTER A-PACE' FROM 85MS TO 37.5MS. IN THIS CASE, CROSSTALK WAS ON-GOING BEYOND THE POST-SHOCK DURATION OF 30 SECONDS AND FALL OUTSIDE OF THE NORMAL BLANKING PERIOD OF 37.5 MS RESULTING IN INHIBITION OF VENTRICULAR PACING. FOLLOWING POST-DEFIBRILLATION, MOVEMENT OF RESIDUAL ENERGY INTO THE MYOCARDIUM CAN INCREASE THE LIKELIHOOD OF AV CROSSTALK THAT WILL EVENTUALLY RESOLVE WITH COMPLETE DISSIPATION OF THE ENERGY IN THE LEAD. THE AVAILABLE PROGRAMMING OPTIONS INCLUDE (1) PROGRAM THE SMART FEATURE OFF AND REPROGRAM THE 'RV-BLANK AFTER A-PACE' TO A FIXED 85MS. HOWEVER, THIS COULD RESULT IN UNDETECTION OF A SLOW VT. (2) REPROGRAM THE DEVICE TO VVI. HOWEVER, A LOSS OF A-V SYNCHRONY COULD RESULT IN WORSENING HEART FAILURE SYMPTOMS. (3) EXTEND THE PATIENT'S POST-SHOCK PACING DURING (AS WAS DONE FOR THIS PATIENT) BEYOND THE NOMINAL SETTING OF 30 SECONDS. THE BLANKING PERIOD EFFECTIVELY REMAINS AT 85MS DURING THE PERIOD WHERE CROSSTALK MAY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R