BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1951443 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22913
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. AS OF TODAY, OUR INVESTIGATION IS COMPLETE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED AN INCREASE IN PACING THRESHOLDS AND LOSS OF CAPTURE. THE PATIENT HAD A COMPETITOR'S RIGHT VENTRICULAR PACE/SENSE LEAD. THE PHYSICIAN WAS PLANNING TO PERFORM A REVISION PROCEDURE IN THE NEAR FUTURE. AT THIS TIME, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED AS A RESULT OF THE ABOVE CLINICAL OBSERVATION. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED ABDOMINAL DISCOMFORT POST IMPLANT, AT THIS TIME, THERE IS NO EVIDENCE TO SUGGEST A PERFORATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PATIENT UNDERWENT A REVISION PROCEDURE AND THE COMPETITOR'S RV LEAD WAS REPOSITIONED. NO FURTHER COMPLETIONS HAVE BEEN 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 70 YR Required Intervention N119| 4548| H177| 4470| (B)(4)| 0158