BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1861094 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15413
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED (B)(6) LATER THAT THE PATIENT ALLEGED THAT THE INFECTION WAS DUE TO A SET SCREW FROM THE DEVICE PROTRUDING THROUGH THE SKIN. THE DEVICE WAS RETRIEVED FROM BOSTON SCIENTIFIC ARCHIVES FOR INVESTIGATION OF THE NEW ALLEGATION IN OUR (B)(4) LABORATORY. THE ANALYSIS CONDUCTED WHEN THE DEVICE WAS INITIALLY RETURNED WAS REVIEWED, AND IT WAS NOTED THAT THE DEVICE HAD MET SPECIFICATIONS IN ELECTRICAL TESTING AT THAT TIME. EXTERNAL VISUAL INSPECTION NOTED THERE WAS BODY FLUID CONTAMINATION IN THE LEAD BARRELS, AND ALL SEAL PLUGS WERE INTACT. THERE WAS NO DAMAGE NOTED FROM A SET SCREW COMING THROUGH OR BEING REINSERTED INTO THE DEVICE HEADER. ALL SET SCREWS OPERATED NORMALLY. AN X-RAY EXAMINATION NOTED NO IRREGULARITIES. THE ALLEGATION OF A PROTRUDING SET SCREW COULD NOT BE CONFIRMED BY OUR ANALYSIS AND TESTING, AS THERE WAS NO EVIDENCE THAT A SET SCREW CAME OUT OF THE DEVICE HEADER.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED 11.2 MONTHS LATER THAT THE PATIENT ALLEGED THAT THE INFECTION WAS DUE TO A SET SCREW FROM THE DEVICE PROTRUDING THROUGH THE SKIN. THE DEVICE WAS RETRIEVED FROM BOSTON SCIENTIFIC ARCHIVES FOR INVESTIGATION OF THE NEW ALLEGATION IN OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE ANALYSIS CONDUCTED WHEN THE DEVICE WAS INITIALLY RETURNED WAS REVIEWED, AND IT WAS NOTED THAT THE DEVICE HAD MET SPECIFICATIONS IN ELECTRICAL TESTING AT THAT TIME. EXTERNAL VISUAL INSPECTION NOTED THERE WAS BODY FLUID CONTAMINATION IN THE LEAD BARRELS, AND ALL SEAL PLUGS WERE INTACT. THERE WAS NO DAMAGE NOTED FROM A SET SCREW COMING THROUGH OR BEING REINSERTED INTO THE DEVICE HEADER. ALL SET SCREWS OPERATED NORMALLY. AN X-RAY EXAMINATION NOTED NO IRREGULARITIES. THE ALLEGATION OF A PROTRUDING SET SCREW COULD NOT BE CONFIRMED BY OUR ANALYSIS AND TESTING, AS THERE WAS NO EVIDENCE THAT A SET SCREW CAME OUT OF THE DEVICE HEADER.

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE ISSUE, NO ANALYSIS WILL BE CONDUCTED IF THE DEVICE IS RETURNED. THIS REPORT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    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 Required Intervention (B)(4)| (B)(4)| (B)(4)| (B)(4)