BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1863686 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-15748
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    August 3, 2010
    Report Date
    September 29, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN, THE DEVICE WAS THOROUGHLY ANALYZED. (B)(4). LABORATORY TECHNICIANS REPORTED A PRISTINE OUTER CASE VISUAL INSPECTION. THE HEADER AND CASE WERE THEN REMOVED AT WHICH TIME THE INTERNAL INSPECTION REVEALED EVIDENCE OF ARCHING DAMAGE. THE DEVICE WAS THEN SENT FOR FURTHER DESTRUCTIVE ANALYSIS, SO AS TO DETERMINE ROOT CAUSE OF THIS INTERNAL ARCHING. MICROGRAPHS ILLUSTRATING INTERNAL DAMAGE ON EACH OF THE DEVICE COMPONENTS WERE PROVIDED; HOWEVER, THE EXTENSIVE DAMAGE TO THE AFFECTED AREAS PREVENTED A CLEAR DETERMINATION OF WHAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS ARCHING EVENT. IT WAS SUSPECT THAT AN INTERNAL FOREIGN MATERIAL COULD HAVE CAUSED THIS PREMATURE DEVICE FAILURE. LABORATORY ENGINEERS WERE ABLE TO CONFIRM APPROPRIATE RIGHT VENTRICULAR PACING THERAPY WITH COMPROMISED DEFIBRILLATION THERAPY.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC, CRM WILL ANALYZE THIS DEVICE UPON RECEIPT AND PROVIDE ADDITIONAL INFORMATION ONCE THE TESTING HAS BEEN COMPLETED AND AN UPDATED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOWING PRODUCT EXPLANT, THE DEVICE WAS RETURNED FOR POST MARKET EVALUATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) GENERATED A FAULT CODE - DISCOVERED UPON DEVICE INTERROGATION - THAT COULD COMPROMISE CRITICAL THERAPY SO AN IMMEDIATE DEVICE REPLACEMENT WAS RECOMMENDED BY OUR TECHNICAL SERVICES DEPARTMENT. MEANWHILE, A MANUAL CAP REFORM WAS PERFORMED, INAPPROPRIATELY SHOCKED THE PATIENT AND THE FAULT CODE RETURNED. THE DEVICE WAS PROGRAMMED TO MONITOR ONLY AND THE DEVICE WAS REPLACED THE NEXT DAY.

    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