BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2040669 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00664
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 11, 2011
    Report Date
    February 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0609-10 TO Z-0610-10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION CONFIRMED THE CLINICAL OBSERVATION OF A WEAKENED HEADER BOND. AN X-RAY OF THE DEVICE HEADER FOUND NO BROKEN HEADER WIRES. PIN GAUGE TESTING CONFIRMED THAT ALL PORT DIAMETERS WERE WITHIN DESIGN SPECIFICATION RANGE; HOWEVER, THE DIAMETER OF THE RV SPRING CONTACT COMPONENT WAS FOUND TO BE OUT-OF-SPECIFICATION. THIS MAY HAVE RESULTED IN A SUBOPTIMAL CONNECTION WITH THE LEAD TERMINAL[S]. ANALYSIS CONCLUDED THE OUT OF RANGE IMPEDANCE MEASUREMENTS WERE LIKELY RELATED TO THE OUT OF SPECIFICATION LEAF SPRING CONTACT COMPONENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, INTERROGATION OF THIS DEFIBRILLATOR REVEALED HIGH OUT OF RANGE RIGHT VENTRICULAR LEAD IMPEDANCE MEASUREMENTS. A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. THIS DEVICE WAS REMOVED AND REPLACED SUCCESSFULLY. UPON REMOVAL, IT WAS NOTED THERE WAS A WEAK END HEADER BOND. THIS DEVICE IS INCLUDED IN THE SUBPECTORAL IMPLANT 2009 PRODUCT ADVISORY. IT WAS THOUGHT THE ISSUE WAS A SYMPTOM OF THE ADVISORY. THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT SYMPTOMS 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 Required Intervention