BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2151105 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07010
    Event Type
    Injury
    Date Received
    July 6, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SHOCKED SEVERAL TIMES FOR A VENTRICULAR ARRHYTHMIA. IT WAS REPORTED THAT THERE WERE TWO ATTEMPTS TO DELIVER ANTI-TACHYCARDIA PACING (ATP). THE ATP CONVERTED THE RHYTHM FOR 4-5 BEATS AND THEN IT WOULD RETURN. THE DEVICE CONTINUED TO TREAT THE ARRHYTHMIA WITH A 5 JOULE SHOCK, A 21 J SHOCK AND THEN SUBSEQUENT 41 J SHOCKS UNTIL THERAPY WAS EXHAUSTED. THERE WAS AN ALLEGATION THAT ALL OF THE PROGRAMMED ATP FOR ATTEMPT 2 WAS NOT USED BEFORE GOING TO THE FIRST SHOCK. IT WAS LATER DISCOVERED THAT ATP HAD TIMED OUT AND APPROPRIATE DEVICE FUNCTION WAS CONFIRMED. IT WAS ALSO REPORTED THAT THE PATIENT HAD A DIFFICULT TIME TOLERATING THE ARRHYTHMIA. IT WAS REPORTED BY THE TIME THE AMBULANCE ARRIVED THE PATIENT WAS BLUE AND THE PATIENT'S SPOUSE THOUGHT THE PATIENT WAS DECEASED. AN ADDITION OF A SUB-Q ARRAY OR REPROGRAMMING TO ACCOMMODATE THE PATIENT'S NEEDS WAS RECOMMENDED BY A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT.

    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 78 YR Life Threatening E030| 4554| 0158| N119