BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1874926 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17930
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE REMAINS IMPLANTED AND IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS ASSOCIATED WITH A REPORT OF LOSS OF CAPTURE AND PATIENT HOSPITALIZATION DUE TO SYNCOPE. A BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT RIGHT VENTRICULAR AND LEFT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS HAD INCREASED BUT WERE WITHIN NORMAL OPERATING RANGE, AND THE PACING THRESHOLDS WERE ADEQUATE. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT (TS) DISCUSSED TROUBLESHOOTING TECHNIQUES TO DETERMINE IF THE CAUSE WAS LIKELY LEAD-RELATED OR DUE TO A LEAD-TISSUE INTERFACE ISSUE RELATED TO PATIENT ARM MOVEMENT.

    Description of Event or Problem · 1

    A BOSTON SCIENTIFIC FIELD REPRESENTATIVE SUBSEQUENTLY REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXPLANTED AND REPLACED DUE TO A FRACTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 52 YR Hospitalization 4542| 0181| 4470| N119