BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043174 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02593
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT WAS FOUND UN-RESPONSIVE. THE SUSPECTED CAUSE OF THE EVENT WAS PNEUMONIA AND POSSIBLE MYOCARDIAL INFARCTION. THE FIELD REPRESENTATIVE WAS CALLED TO CHECK THE DEVICE. THE PATIENT HAS HAD CHRONICALLY HIGH LEFT VENTRICULAR (LV) LEAD IMPEDANCE MEASUREMENTS WITH APPROPRIATE FUNCTION. RIGHT VENTRICULAR (RV) SHOCK IMPEDANCE MEASUREMENTS JUMPED BETWEEN 60 & 200 OHMS UNTIL TWO MONTHS AGO. NOW SHOCK IMPEDANCE MEASUREMENTS ARE GREATER THAN 200 OHMS. THE PATIENT HAD NOT HAD A CLINIC CHECK SINCE THEIR OLD DEVICE WAS REPLACE FOUR MONTHS PRIOR. THE PATIENT WAS INTUBATED AND ADMITTED TO THE INTENSIVE CARE UNIT. THE FAMILY IS DEBATING PLACING THE PATIENT ON DNR STATUS. UPON REVIEW OF THE STORED EPISODES IN THE DEVICE MEMORY, IT APPEARS THERE WAS ON NON-SUSTAINED EPISODE AT 3 AM WHICH CONTAINED FIFTEEN FAST BEATS. NO NOISE WAS NOTED AND ALL ELECTROGRAMS WERE CLEAN. THE HIGH SHOCK IMPEDANCE MEASUREMENTS WERE DISCUSSED WITH THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PATIENT'S STATUS WAS UPDATED TO DNR AND TACHY THERAPY WAS TURNED "OFF" ON THE DEVICE. THERE WAS NO ALLEGATION THAT THE OUT-OF-RANGE MEASUREMENTS CONTRIBUTED TO THE PATIENT'S EVENT, AND THERE WAS NO ALLEGATIONS AGAINST THE DEVICE PERFORMANCE IN RELATION TO THE PATIENT'S ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144996 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 4015| 4456| N119| H217| 4016| 0185| 4555| 1270