BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3212609 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09773
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER AND PROGRAMMING OPTIONS. THE PHYSICIAN IS NOT CERTAIN IF THE SYNCOPE WAS DUE TO VT OR DISCRIMINATION ISSUES DUE TO THE POOR ATRIAL SENSING. THE PATIENT WILL BE FOLLOWING UP WITH HIS PHYSICIAN AT AN UNKNOWN DATE IN THE FUTURE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED A SYNCOPAL EPISODE, FELL AND HIT HIS HEAD. IT IS UNKNOWN IF THE FALL WAS PRIOR TO RECEIVING A SHOCK OR AS A RESULT OF THE SHOCK. DEVICE EVALUATION NOTED THAT THE PATIENT HAD VENTRICULAR TACHYCARDIA (VT) WITH SEVEN BURSTS OF ANTI-TACHYCARDIA PACING (ATP) FOLLOWED BY ELEVEN AND A 26J SHOCK. ADDITIONALLY, ATRIAL UNDERSENSING WAS NOTED. THE ATRIAL SENSITIVITY WAS PROGRAMMED AT .25MV AND WAS REPROGRAMMED TO .15MV WHICH PRODUCED NOISE ON THE ATRIAL LEAD. THE PHYSICIAN IS CONCERNED WITH THE INTEGRITY OF THE COMPETITIVE ATRIAL LEAD AS THE IMPEDANCE FLUCTUATES BETWEEN 540 OHMS AND LESS THAN 200 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311947 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| O 1488T| H170| 4538| N119| 1861| 0148