BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3210121 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07153
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    May 14, 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
    OTHER

    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 LOW VOLTAGE BATTERY FAULTS (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. THE FIELD OBSERVATION WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED A STATE THAT REMOTE MONITORING WAS DISABLED DUE TO LIMITED BATTERY CAPACITY. THE ALERT HISTORY WAS REVIEWED AND APPROXIMATELY A MONTH PRIOR TO THIS AN ALERT THAT VOLTAGE WAS TOO LOW FOR REMAINING BATTERY CAPACITY HAD BEEN TRIGGERED IN THE DEVICE. THERE WAS ALSO AN ALERT FOR A CHARGE TIME OUT, AND IT WAS UNCLEAR IF THE LOW BATTERY CAPACITY CAUSED THAT. THE PATIENT WAS AWAY FROM THE REMOTE COMMUNICATOR FOR TWO MONTHS, AND THEREFORE, THE INFORMATION WAS RECENTLY TRANSMITTED. THE HEALTH CARE PROFESSIONAL (HCP), PHYSICIAN, AND FIELD REPRESENTATIVE REVIEWED THE INFORMATION WITH BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). IT WAS DISCUSSED THAT THERE WAS A LARGER CURRENT DRAW THAN NORMAL AND THE BATTERY WAS SO LOW THAT REMOTE MONITORING WAS TURNED OFF; DEVICE REPLACEMENT WAS RECOMMENDED AS THERAPY AVAILABILITY WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE RADIATION TREATMENTS FOR THYROID CANCER, AND THAT THE TREATMENTS WERE UNSHIELDED. THE PHYSICIAN THOUGHT THAT PERHAPS THAT IMPACTED THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310467 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R 4135| 4592| 0184| 4554| N119| 4555