BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3905267 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09812
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 22, 2014
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNDERGOING DETAILED ANALYSIS TO DETERMINE ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. REVIEW OF THE DEVICE MEMORY VERIFIED THAT THE DEVICE HAD NO VOLTAGE ALERTS (CODE 1003) HAD BEEN RECORDED. EXTERNAL VISUAL INSPECTION OF THE DEVICE NOTED NO ANOMALIES. THE DEVICE WAS PUT THROUGH A SERIES OF AUTOMATED DIAGNOSTIC TESTING THAT VERIFIES THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE FAILED SEVERAL TESTS AS A RESULT OF LOW BATTERY VOLTAGE. 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. ON AUGUST 29, 2013, BOSTON SCIENTIFIC DISTRIBUTED A LETTER TO PHYSICIANS CONCERNING THIS ISSUE. THIS LETTER INFORMED PHYSICIANS THAT, IN A SUBSET OF DEVICES, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS DEVICE IS NOT A PART OF THE IDENTIFIED POPULATION.

    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 NOT INCLUDED IN THE AUGUST 29, 2013 ADVISORY POPULATION, BUT WAS ADDED TO THE EXPANDED POPULATION ON SEPTEMBER 17, 2014.

    Description of Event or Problem · 1

    AS PART OF AN ANALYSIS TO REVIEW THE SAFETY ARCHITECTURE LOW VOLTAGE ALERT (CODE 1003), BATTERY VOLTAGE DATA WAS PULLED FROM THE REMOTE PATIENT MONITORING SYSTEM. DURING OUR ANALYSIS, THE DEVICE WAS IDENTIFIED AS DEMONSTRATING EVIDENCE OF PREMATURE BATTERY DEPLETION THAT COULD POTENTIALLY LEAD TO COMPROMISED THERAPY IF NOT ADDRESSED IN A TIMELY MANNER. BOSTON SCIENTIFIC TECHNICAL SERVICES PROACTIVELY REACHED OUT TO THE LOCAL REPRESENTATIVE TO NOTIFY THEM OF THIS FINDING AND RECOMMEND DEVICE REPLACEMENT. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382101 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 5076| N119| 7120| MISMATCH