BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1871152 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17401
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    July 19, 2010
    Report Date
    August 24, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS SCHEDULED. NO FURTHER INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT, DURING A PRE-DISCHARGE FOLLOW-UP AFTER AN IMPLANT PROCEDURE, THIS DEVICE HAD DETECTED A LEFT VENTRICULAR (LV) IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS ON A COMPETITOR LEAD. LV LOSS OF CAPTURE WAS ALSO OBSERVED. HIGH IMPEDANCE AND LV LOSS OF CAPTURE WERE OBSERVED IN BOTH UNIPOLAR AND BIPOLAR PACING MODES. THE SYSTEM WAS EXAMINED UNDER FLUOROSCOPY AND IT WAS NOTED THE LV LEAD WAS NOT FULLY INSERTED INTO THE DEVICE LEAD PORT. NO ADVERSE PATIENT EFFECTS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention