BEUDAMED
    FDA Adverse Event Death Summary report: N

    COGNIS

    MDR report key: 1698266 · Received May 25, 2010

    Report

    Report Number
    2124215-2010-11508
    Event Type
    Death
    Date Received
    May 25, 2010
    Date of Event
    May 24, 2010
    Report Date
    September 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE HAS BEEN RETURNED AND IS CURRENTLY UNDERGOING ANALYSIS. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THAT THIS DEVICE REMAINS IMPLANTED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    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 PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WERE ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS DEVICE WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE INITIAL FIELD REPRESENTATIVE (FR) WAS CONTACTED AGAIN RELATING TO THIS ISSUE. THE FR INDICATED THAT HE HAD NO KNOWLEDGE OF THE SITUATION AND THAT THE PATIENT WAS NO LONGER BEING FOLLOWED BY THE SAME PHYSICIAN. THE FR INDICATED THAT THE PATIENT WAS CURRENTLY BEING FOLLOWED BY A SPECIFIC PHYSICIAN IN (B) (6). A FR IN THE (B) (4) AREA WAS CONTACTED AND VISITED THE PHYSICIAN'S OFFICE IN ORDER TO LOCATE THE PATIENT'S CHART; HOWEVER, THEY HAD NO RECORD OF THIS PATIENT. ALL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS PATIENT HAVE BEEN UNSUCCESSFUL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS FEELING FATIGUED AND SHORT OF BREATH. THE PATIENT INDICATED THAT HE HAD A SEVERE HEADACHE AND SAT DOWN. THE PATIENT'S WIFE LEFT THE PATIENT FOR 15 MINUTES AND WHEN SHE RETURNED, THE PATIENT WAS NOT BREATHING. THE PATIENT PASSED AWAY. IT WAS NOTED THAT THERE WAS ARCHING OF A LEAD ON THE DEVICE, ALTHOUGH WHICH LEAD IS UNKNOWN. THE PATIENT IS UNDERGOING AN AUTOPSY AND WILL BE CREMATED. TECHNICAL SERVICES (TS) RECOMMENDED THEY TURN OFF THE DEVICE OR INTERROGATE THE DEVICE PRIOR TO EXPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    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 65 YR Death 0185| 4512| N118| 4470| H179