BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3043267 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-03783
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0087-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    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 ONE LOW VOLTAGE BATTERY FAULT (FAULT CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. INITIAL AUTOMATED TESTING VERIFIED BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE. 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 CAPACITOR(S) 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. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE YELLOW ALERT WAS GENERATED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) ; THE FOLLOWING ERROR MESSAGE (I.E., FAULT CODE 1003) WAS DETECTED: "VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY". BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND NOTED THAT APPEARANCE OF THIS FAULT CODE WAS INDICATIVE OF A BATTERY-RELATED ISSUE WITH THE DEVICE. AS SUCH, THE TS CONSULTANT ADVISED REPLACEMENT OF THE DEVICE. THE TS CONSULTANT ALSO RECOMMENDED PREPARING A SAVE ALL TO DISK/MEMORY DUMP IN ORDER TO ASSESS THE CURRENT DRAIN ON THE DEVICE'S BATTERY. IN ORDER TO EXPEDITE THIS ANALYSIS AND, AS AN ALTERNATIVE TO BRINGING THE PATIENT INTO THE DEVICE CLINIC TO PREPARE A COPY OF THE DEVICE MEMORY, PERMISSION WAS REQUESTED TO ACCESS THIS PATIENT'S DEVICE DIAGNOSTIC DATA VIA THE LATITUDE REMOTE PATIENT MONITORING SYSTEM. BOSTON SCIENTIFIC FAILURE ANALYSIS ENGINEERS REVIEWED THE DEVICE DIAGNOSTIC DATA AVAILABLE IN LATITUDE AND CONFIRMED THAT THE LOW VOLTAGE FAULT CODE WAS VALID; THIS FAULT WAS DECLARED (ON (B)(6) 2013) DUE TO AN ACCELERATED DEPLETION OF THE BATTERY. BASED ON THE DEVICE'S BATTERY VOLTAGE MEASUREMENTS, THE OVERALL RATE OF DEPLETION APPEARS TO BE CONSTANT. ENGINEERS ESTIMATE THAT THE REMAINING BATTERY CAPACITY (BASED ON THE ACTUAL VOLTAGE LEVEL AND CAPACITY CONSUMED) SHOULD BE SUFFICIENT TO PROVIDE BOTH BRADYCARDIA AND TACHYCARDIA THERAPIES; HOWEVER, A RELIABLE PREDICTION FOR HOW LONG THESE FEATURES CAN BE SUPPORTED CANNOT BE MADE. SINCE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE (I.E., COMPONENT RESPONSIBLE) FOR THE PREMATURE BATTERY DEPLETION OR PREDICT FUTURE BEHAVIOR OF THE DEVICE BASED SOLELY ON REVIEW OF THE DEVICE DIAGNOSTIC DATA AVAILABLE VIA LATITUDE, THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145851 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R 0185| 1270| 4136| 4243| 4470| 6987| 4285| N118| 4135| H175| 4518