BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3041241 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-01334
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 29, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0025-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS INCLUDED IN THE ADVISORY POPULATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT A LOW VOLTAGE BATTERY FAULT(FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. AFTER THE TITANIUM CASE WAS OPENED, MICROSCOPIC VISUAL INSPECTION DID NOT REVEAL ANY IRREGULARITIES. THE BATTERY WAS THEN REMOVED, SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT USAGE WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO TWO COMPROMISED LOW VOLTAGE CAPACITORS THAT ARE CONNECTED TO THE DEVICE'S BATTERY. THIS TYPE OF COMPONENT MALFUNCTION CAN RESULT IN A HIGH CURRENT DRAIN, WHICH OVER TIME CAN RESULT IN PREMATURE BATTERY DEPLETION, AS WAS OBSERVED IN THIS CASE.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A PRODUCT EXPERIENCE REPORT (PER) FORM THAT WHEN THE REPLACEMENT DEVICE WAS CONNECTED TO THE CHRONIC RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD, A GREATER THAN 200 OHMS SHOCK IMPEDANCE WAS RECORDED IN ALL SHOCK CONFIGURATIONS EXCEPT RV (COIL) TO CAN. THE LOCAL REPRESENTATIVE SUSPECTS THAT THE RV DEFIBRILLATION LEAD MAY HAVE BEEN DAMAGED DURING THE REPLACEMENT PROCEDURE. THE CHRONIC RV DEFIBRILLATION LEAD WAS SURGICALLY CAPPED AND REPLACED. THE REPLACEMENT DEVICE REMAINS IN-SERVICE. UPON RETURN, THE DEVICE WILL UNDERGO DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS DEVICE DISPLAYED A FAULT CODE#1003. THE LOCAL REPRESENTATIVE WAS PLANNING TO SEND A MEMORY UPLOAD BACK TO BOSTON SCIENTIFIC FOR ANALYSIS. TWO DAYS LATER, THE PATIENT REPORTED THAT THE DEVICE WAS GENERATING BEEPING TONES. TS INFORMED THE LOCAL REPRESENTATIVE THAT THE PATIENT NEEDS TO BE SEEN IN THE CLINIC FOR DEVICE FOLLOW-UP AND THAT THE BEEPING TONES WERE MOST LIKELY RELATED TO THE FAULT CODE#1003. THE MEMORY UPLOAD WAS RECEIVED FOR ANALYSIS. ADDITIONALLY, A HEALTH CARE PROFESSIONAL (HCP) CONTACTED TS TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM HAD DETECTED A YELLOW ALERT (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY). TS EXPLAINED THE ISSUE AND PLANNED TO HAVE THE LOCAL REPRESENTATIVE CONTACT THE CLINIC. THE MEMORY UPLOAD DATA WAS REVIEWED BY BOSTON SCIENTIFIC'S IN-HOUSE ENGINEERING AND A LOW VOLTAGE FAULT HAD BEEN DECLARED DUE TO THREE VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE WAS 3.021 VOLTS AND THERAPY DELIVERY WAS UNAFFECTED. USING THE LAST YEARS' WORTH OF DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE ESTIMATED TRUE DEPTH OF BATTERY DISCHARGE TO OBTAIN AN ESTIMATE OF THE FAULT CURRENT WAS PLOTTED. THE CURRENT APPEARS STEADY WITH AN ADDITIONAL CURRENT DRAIN OF MORE THAN 47UA OVER THE EXPECTED NOMINAL VALUE OF 16UA. TO DATE, THE BEHAVIOR APPEARS CONSISTENT OVER TIME, HOWEVER, THIS MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. THE DATA INDICATES THAT THERE IS SUFFICIENT RESERVE FOR THE DEVICE TO MAINTAIN NORMAL THERAPY FUNCTIONS FOR 2 WEEKS TIME. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED. THE DEVICE IS ENROUTE TO BOSTON SCIENTIFIC FOR LABORATORY TESTING.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143752 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4518| 4470| 0186| 4525| N118| H179