BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2780085 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12515
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    January 1, 2012
    Report Date
    October 10, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE EVIDENCE INDICATES THE SYSTEM REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    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. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THE PATIENT WAS SEEN FOR A REVISION PROCEDURE. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE IS TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE DEVICE HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD WAS SEEN FOR ROUTINE FOLLOW UP. UPON INTERROGATION, THE DEVICE REVEALED AN EPISODE OF NOISE FROM (B)(6) 2012. THE NOISE WAS OVERSENSED AND LED TO PACING INHIBITION WITH APPROXIMATELY TWO SECONDS OF ASYSTOLE. THE INTERROGATION ALSO REVEALED A ' CHECK RV LEAD MESSAGE. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE (FR) INDICATED THE MESSAGE WAS DETERMINED TO BE FROM A LOW, INTRINSIC R-WAVE AMPLITUDE READING. THE FR REPORTED THAT THE PATIENT WAS IN COMPLETE HEART BLOCK, THEREFORE, THERE WERE NO R WAVES TO MEASURE. SUBSEQUENTLY, A LOCAL FR INDICATED THAT THE PATIENT WOULD BE SEEN AT A LATER DATE FOR A DEVICE CHANGE OUT PROCEDURE AND AT THAT TIME, A NEW RV LEAD WOULD BE IMPLANTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR 0157| H179| 4512| 4469| H175| N118