BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3040703 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00576
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 13, 2012
    Report Date
    January 28, 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 Occupation
    HEALTH PROFESSIONAL

    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

    THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS ON-GOING AS A REQUEST HAS BEEN MADE TO THE LOCAL REPRESENTATIVE FOR ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION FOUND THAT THE DEVICE WAS RETURNED WITHOUT THE LV SETSCREW AND SEAL PLUG. MICROSCOPIC EXAMINATION NOTED DAMAGE TO LV TERMINAL BLOCK THREADS IN FOUR PLACES ON THE LOWER TWO THREADS. THE METAL IS CUT AWAY IN "V" SHAPED WEDGES. A SETSCREW WAS PLACED IN THE LV TERMINAL BLOCK AND THE SCREW TRAVELS SMOOTHLY UP AND DOWN IN THE TERMINAL BLOCK. REVIEW OF THE DEVICE MEMORY CONFIRMED THAT THREE LOW VOLTAGE BATTERY FAULTS (FAULT CODE 1003) HAD BEEN RECORDED RESULTING IN A FAULT CODE ALERT ON (B)(6) 2012. 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 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.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE IS ENROUTE FOR LABORATORY TESTING. ACCORDING TO THE IMPLANT FORM, THE PHYSICIAN EXPERIENCED DIFFICULTIES WITH THE LEFT VENTRICULAR (LV) SET SCREW. EVENTUALLY, THE PHYSICIAN WAS ABLE TO LOOSEN THE SET SCREW AND REMOVED THE LV TERMINAL PIN FROM THE LV HEADER PORT. THE DEVICE WAS REPLACED WITHOUT INCIDENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CLINIC NURSE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT'S MONITORING SYSTEM DETECTED A YELLOW ALERT ASSOCIATED WITH A FAULT CODE#1003. THE CLINIC NURSE WAS AWARE THAT THE DEVICE SHOULD BE REPLACED AND WAS PLANNING TO SPEAK WITH THE PHYSICIAN TO DISCUSS FURTHER. SUBSEQUENTLY, THE LOCAL REPRESENTATIVE CONTACTED TS TO REPORT THAT THIS DEVICE WAS EXPLANTED IN (B)(6) 2013.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143184 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4470| N118| 1823| H175| MISMATCH| 4513