BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1850270 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-15364
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    July 6, 2010
    Report Date
    August 17, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. WHEN THE REVISION PROCEDURE HAS BEEN PERFORMED OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. IT WAS NOTED THAT ON THREE SIDES OF THE HEADER, MEDICAL ADHESIVE WAS BONDED TO THE HEADER, BUT NOT THE CORRESPONDING AREA OF THE DEVICE CASE. COMPOSITIONAL ANALYSIS COMPLETED ON SAMPLE AREAS WHERE THE HEADER WAS LOOSE FROM THE DEVICE CASE VERIFIED A UNIFORM LAYER OF MEDICAL ADHESIVE ON THE HEADER AND VERY LITTLE MEDICAL ADHESIVE ON THE TITANIUM CASE. AN X-RAY OF THE DEVICE HEADER FOUND THE DF HEADER WIRE WAS FRACTURED AND THE RV HEADER WIRE REVEALED FRACTURE MARKS. ALL OTHER HEADER WIRES WERE INTACT. DETAILED ANALYSIS REVEALED THAT THE RV HEADER WIRE FRACTURED DUE TO FATIGUE. DAILY RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS WERE STABLE THROUGHOUT THE DEVICE LIFETIME AND RIGHT VENTRICULAR PACING WAS AVAILABLE. ANALYSIS CONCLUDED THE REPORTED CLINICAL ALLEGATION WAS DUE TO THE WEAKENED HEADER BOND.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD AND DEVICE IMPLANTED IN THE SUBPECTORAL BODY LOCATION DISPLAYED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE DEVICE IS INCLUDED IN THE SUBPECTORAL IMPLANT 2009 ADVISORY COMMUNICATED ON 12/1/2009. FIVE MONTHS EARLIER, THE SHOCK IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL VALUES. RIGHT VENTRICULAR IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. FLUOROSCOPY DID NOT REVEAL ANY ISSUES WITH THE SETSCREW OR WITH THE LEAD. A CHEST XRAY WILL BE PERFORMED. THE SHOCK IMPEDANCE MEASUREMENTS REMAINED INCREASED IN ALL THREE SHOCK VECTORS. THERE WAS CONCERN OF A LEAD PROXIMAL COIL ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED; A COMMANDED SHOCK WAS PERFORMED; A FAULT CODE WAS REVEALED. AFTER FURTHER DISCUSSION WITH A TECHNICAL SERVICES CONSULTANT, THE PATIENT WAS DISCHARGED AND SCHEDULED FOR A REVISION PROCEDURE IN THE NEAR FUTURE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. A PROCEDURE WAS PERFORMED; FURTHER TESTING WAS CONDUCTED AND FLUOROSCOPIC IMAGES WERE OBTAINED. NO CONNECTION ISSUES WERE REVEALED. A VISUAL INSPECTION REVEALED THE HEADER APPEARED LOOSE AND COULD BE MANIPULATED. A DECISION WAS MADE TO REPLACE THE DEVICE. THIS DEVICE WAS REMOVED, REPLACED AND WILL BE RETURNED FOR ANALYSIS. THE LEADS WERE RECONNECTED TO THE REPLACEMENT DEVICE AND NORMAL MEASUREMENTS WERE OBTAINED. NO 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 P107

    Patients

    Seq Age Sex Outcome Treatment
    1