BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2042484 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-02431
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    1-1188523903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AWAITING RETURN OF DEVICE TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED IN (B)(6) WITHOUT INCIDENT. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS. AN ATTEMPT TO INTERROGATE THE DEVICE BY BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY WAS UNSUCCESSFUL. THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS TO DETERMINE ROUTE CAUSE. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT HAS HAD A HISTORY OF POCKET REVISIONS ASSOCIATED WITH POCKET SWELLING AND REDNESS. THE LOCAL REPRESENTATIVE DISCUSSED THE POSSIBILITY OF AN ALLERGIC REACTION TO THE IMPLANTED SYSTEM AS THE PATIENT EXPERIENCED SIMILAR SYMPTOMS WITH PAST IMPLANTED DEVICES. AT THE TIME OF THE EXPLANT PROCEDURE, THE POCKET WAS OPENED AND VISUAL INSPECTION IDENTIFIED AN EXCESSIVE AMOUNT OF SCAR TISSUE BUILD-UP ON TOP OF THE DEVICE. THE ENTIRE SYSTEM WAS EXTRACTED AND THE PATIENT HAS BEEN SCHEDULED FOR CONSULTATION WITH A PLASTIC SURGEON TO ADDRESS THE ISSUES WITH THE POCKET SITE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH AN EXTERNAL LIFE VEST SYSTEM AND WILL FOLLOW-UP WITH THE PHYSICIAN IN 30 DAYS TO DISCUSS IMPLANTATION OF ANOTHER DEVICE/LEAD SYSTEM.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE HAD NO TELEMETRY. VISUAL INSPECTION IDENTIFIED TOOL MARKS ON THE HEADER. ALL OF THE SEAL PLUGS WERE INTACT AND ALL OF THE SET SCREWS OPERATED NORMALLY. THE DEVICE CASING WAS OPENED AND ELECTRICAL MEASUREMENT FOUND THAT THIS DEVICE'S BATTERY WAS SEVERELY DEPLETED. AN EXTERNAL POWER SUPPLY WAS CONNECTED TO THE DEVICE AND THE ELECTRICAL CURRENT WAS MONITORED. DURING THE MONITORING PROCESS A HIGH CURRENT CONDITION WAS OBSERVED. ELECTRICAL TESTING AND ANALYSIS WERE THEN CONDUCTED, WHICH ISOLATED THE HIGH CURRENT TO AN INTEGRATED CIRCUIT (IC). DETAILED ANALYSIS CONFIRMED THAT THE IC ISSUE CREATED THE HIGH CURRENT CONDITION AND THE REPORTED LOSS OF TELEMETRY. IT WAS CONCLUDED THAT THE NO TELEMETRY CONDITION WAS DUE TO A DEPLETED BATTERY. THE CAUSE OF THE DEPLETED BATTERY WAS DUE TO A HIGH CURRENT DRAIN WITHIN THE DEVICE'S INTEGRATED CIRCUITRY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS FIELD CLINICAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS DEVICE COULD NOT BE INTERROGATED BY THIS PATIENT'S LATITUDE MONITORING SYSTEM. THE PATIENT'S HISTORY IS REMARKABLE FOR A PRIOR ADMISSION TO THE EMERGENCY ROOM (ER) FOLLOWING AN EPISODE OF ATRIAL FIBRILLATION (AF). THE PATIENT WAS INSTRUCTED TO CONTACT THE DEVICE-FOLLOWING PHYSICIAN TO HAVE THE DEVICE INTERROGATED. THE PATIENT WAS PRESENTED FOR AN IN-CLINIC FOLLOW-UP AND THE DEVICE COULD NOT BE INTERROGATED VIA RF TELEMETRY. THE FIELD CLINICAL REPRESENTATIVE VERIFIED WITH MEDICAL RECORDS THAT THIS WAS A BOSTON SCIENTIFIC DEVICE. THE RF TELEMETRY FEATURE WAS PROGRAMMED OFF AND RE-INTERROGATION ATTEMPTS WITH A WANDED PROGRAMMER WAS UNSUCCESSFUL. ANOTHER WANDED PROGRAMMER WAS USED WITHOUT SUCCESSFUL INTERROGATION. DESPITE MOVING THE PATIENT INTO ANOTHER ROOM, RF AND WANDED INTERROGATION WAS UNSUCCESSFUL. MAGNET PLACEMENT OVER THE DEVICE DID NOT GENERATE BEEPING TONES. IN ADDITION TO THE NO TELEMETRY STATE, THERE WAS NO BIVENTRICULAR PACING PRESENT AND THE DEVICE WAS NOT IN SAFETY CORE. THE PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT. THE PHYSICIAN EXPRESSED CONCERN ABOUT THE POSSIBILITY OF A LOOSE HEADER AS THE DEVICE HAD BEEN IMPLANTED IN A SUBPECTORAL LOCATION. THE PHYSICIAN WAS PLANNING TO OBTAIN X-RAYS AND CINE FILMS TO FULLY VISUALIZE THE HEADER. DURING THE PROCEDURE, THE PHYSICIAN PLANS TO CHECK THE CONDITION OF THE HEADER AND WILL REMOVE THE DEVICE FOR RETURN AND LABORATORY TESTING. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE SCHEDULED DEVICE REPLACEMENT WAS CANCELLED. THE REPLACEMENT PROCEDURE HAS BEEN RESCHEDULED FOR MID-(B)(6) 2011.

    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 10763 DA N119| H217| 4542| MISMATCH| T127| 4136| 1831| 1388TC| 0155