BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3951191 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-14267
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 12, 2014
    Report Date
    December 5, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). RECORDS INDICATE THIS SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE TREND AND NOTED THAT THE SHOCKING LEAD IMPEDANCE MEASUREMENTS HAD BEEN GRADUALLY INCREASING. ADDITIONAL INFORMATION INDICATED THAT MONITORING WILL CONTINUE THROUGH NORMAL FOLLOW-UPS. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT THE SYSTEM CONTINUED TO EXHIBIT HIGH OOR SHOCK LEAD IMPEDANCE MEASUREMENT. THE PATIENT WILL CONTINUE TO BE MONITORED. ATTEMPTS TO OBTAIN FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE CAUSE OF THE OBSERVATION REMAINS UNDETERMINED AT THIS TIME. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428018 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR 5076| N119| 8040| 0184| H170| 4193