BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS 100-D

    MDR report key: 1460260 · Received August 25, 2009

    Report

    Report Number
    1460260
    Event Type
    Malfunction
    Date Received
    August 25, 2009
    Date of Event
    August 10, 2009
    Report Date
    August 25, 2009
    Manufacturer
    BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT WAS IN FOR A PLANNED CHANGE OF DEFIBRILLATOR GENERATOR AND UPGRADE TO A CRT-D. THE PATIENT'S OLD DEVICE WAS DISCONNECTED FROM THE LEADS AND A COGNIS 100-D CRT-D WAS CONNECTED. THERE WAS NO EFFECTIVE CAPTURE OF MYOCARDIAL TISSUE WITH THE DEVICE APPEARING TO OUTPUT A PACING STIMULUS. THE PHYSICIAN REMOVED THE DEVICE AND INSERTED A SECOND NEW BSC COGNIS CRT-D GENERATOR AND CONNECTED THE LEADS WITH THE SAME RESULT. THE BSC FIELD CLINICAL ENGINEER RECOMMENDED ATTACHMENT OF THE PROXIMAL COIL WHICH RESOLVED THE CAPTURE ISSUE. THERE WAS NO HARM TO THE PATIENT. THE HOSPITAL RETURNED THE INITIAL DEVICE TO THE BSC FIELD REP FOR TESTING AND REVIEW. MANUFACTURER RESPONSE (AS PER REPORTER) FOR ICD, COGNIS 100-D CRT-DWE HAVE ASKED THE MANUFACTURER TO SHARE THE INFORMATION WITH THE HOSPITAL WHEN ANALYSIS IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS 100-D DEFIBRILLATOR, CRT NIK BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR