BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3043148 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02714
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 19, 2010
    Report Date
    November 3, 2015
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Removal / Correction Number
    Z-0087-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUR RECORDS INDICATE THIS DEVICE REMAINS IMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF THE DEVICE MEMORY INDICATED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. THIS CODE FIRST OCCURRED OVER 19 MONTHS AFTER EXPLANT. NO CODES WERE NOTED IN THE DEVICE MEMORY FROM PRIOR TO EXPLANT. THE DEVICE DID NOT DECLARE ELECTIVE REPLACEMENT INDICATOR (ERI) PRIOR TO EXPLANT AND WAS NOTED TO BE AT THE BATTERY STATUS OF GOOD WHEN EXPLANTED. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING, PACING AND SHOCKING FUNCTIONS OF THE DEVICE WERE VERIFIED. THE TITANIUM CASE WAS OPENED AND THE BATTERY WAS REMOVED SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER THAN NORMAL CURRENT DRAIN WAS OBSERVED. ELECTRICAL TESTING ISOLATED THE HIGH CURRENT CONDITION TO A LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE'S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE'S HIGH VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE'S BATTERY FASTER THAN NORMAL. 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. ANALYSIS WAS UNABLE TO CONFIRM ANY OF THE ALLEGATIONS FROM THE FIELD

    Description of Event or Problem · 1

    THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS ELECTIVELY EXPLANED OVER FOUR YEARS LATER. THE DEVICE WAS RETURNED FOR ANALYSIS A YEAR AND A HALF AFTER EXPLANT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. NOISE WAS ALSO PRESENT WHICH RESULTED IN NON-SUSTAINED EPISODES. IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF OVERSENSING. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED REGARDING THIS ISSUE AND REVIEWED AN ELECTROGRAM (EGM) STRIP. TS INDICATED THAT THE NOISE ON THE RIGHT VENTRICULAR (RV) LEAD OCCURRED AT THE SAME TIME AS THE SHOCK AND THERE IS A LARGE CHANGE IN BASELINE WHICH IS INDICATIVE OF A LEAD ISSUE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147720 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR 1194| N119| 5076| 4542| H120| 4088| 4195