BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2780011 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13431
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    August 29, 2012
    Report Date
    September 8, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS SCHEDULED FOR ANOTHER REVISION PROCEDURE TO OCCUR AT A LATER DATE. RECORDS INDICATE THIS LEAD REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) UNDERWENT A RIGHT VENTRICULAR (RV) LEAD REVISION DUE TO A MICRO-DISLODGEMENT WHICH RESULTED IN LOSS OF CAPTURE. THE LEAD WAS SUCCESSFULLY REPOSITIONED. THREE DAYS AFTER THE REVISION PROCEDURE, A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. NO ADDITIONAL 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 64 YR 4470| 4543| 0185| N119