BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1870934 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-16888
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    July 7, 2010
    Report Date
    August 25, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A LOOSE SETSCREW WAS SUSPECTED. THE POCKET WAS OPENED AND THE LEAD WAS RE-SEATED INTO THE HEADER. ALL IMPEDANCES RETURNED TO NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT ONE DAY POST IMPLANT, THIS DEVICE DETECTED HIGH OUT OF RANGE LEFT VENTRICULAR IMPEDANCES.

    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 83 YR Required Intervention 0158| 4592| N119| 4555| 4470