BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2910181 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15581
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    October 31, 2012
    Report Date
    December 27, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDERGOING LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    DUE TO A LEGAL HOLD STATUS, NO FURTHER INFORMATION CONCERNING THIS DEVICE'S OPERATION OR FUNCTIONALITY IS EXPECTED AT THIS TIME. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED AND/OR THE LABORATORY TESTING OF THIS DEVICE IS COMPLETED.

    Additional Manufacturer Narrative · 1

    AWAITING CONFIRMATION THAT THIS DEVICE WAS EXPLANTED AND REPLACED. UPON RETURN, THE DEVICE WILL UNDERGO LABORATORY TESTING TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED IN (B)(6) 2012. THE DEVICE WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT NOTICED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BEEPING ON DIFFERENT OCCASIONS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT THE DEVICE IS DESIGNED TO BEEP FOR A VARIETY OF REASONS AND IS EXPECTED BEHAVIOR DEPENDING ON THE REASON. TS REFERRED THE PATIENT TO HIS PHYSICIAN AND TO HAVE HIS DEVICE CHECKED. THE DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS HEALTH CARE PROFESSIONAL (HCP) CONTACTED TS TO REPORT THAT A SAVE-TO-DISK WAS ENROUTE TO DETERMINE REMAINING LONGEVITY. THE PATIENT WAS SEEN IN-CLINIC FOR A SCHEDULED DEVICE CHECK. UPON INTERROGATION, A FAULT CODE#1003 (VOLTAGE TOO LOW FOR PROJECTED REMAINING CAPACITY) WAS DISPLAYED. TS DISCUSSED THE ISSUE AND RECOMMENDED DEVICE REPLACEMENT. A DISK WAS RECEIVED AND ANALYSIS FOUND THAT A LOW VOLTAGE FAULT WAS DECLARED IN EARLY-OCTOBER 2012 DUE TO THREE DAILY VOLTAGES BEING BELOW THE THRESHOLD OF 3.025 VOLTS. THE VOLTAGE IS CURRENTLY 2.982 VOLTS AND THERAPY DELIVERY IS UNAFFECTED. USING THE LAST YEARS' WORTH OF DAILY BATTERY VOLTAGE MEASUREMENT DATA, THE ESTIMATED TRUE DEPTH OF BATTERY DISCHARGE WAS PLOTTED TO OBTAIN AN ESTIMATE OF THE FAULT CURRENT. THE CURRENT APPEARS STEADY WITH AN ADDITIONAL CURRENT DRAIN OF 99 UA OVER THE EXPECTED NOMINAL VALUE OF 21UA. TO DATE, THE BEHAVIOR APPEARS CONSISTENT OVER TIME, HOWEVER, THIS CONDITION MAY CHANGE UNPREDICTABLY. AT THIS POINT, THE BATTERY DOES HAVE A SIGNIFICANT RESERVE CAPACITY. IF THE FAULT CURRENT WERE TO INCREASE SEVERAL TIMES MORE THAN THE MAXIMUM CALCULATED CURRENT, THEN THE DEVICE MAY LOSE THE ABILITY TO DELIVER THERAPY WITHIN A REPLACEMENT WINDOW OF 2 WEEKS. BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAS BEEN SCHEDULED FOR DEVICE REPLACEMENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAD RECEIVED INFORMATION BACK IN 2011 INDICATING THAT THIS PATIENT OR A REPRESENTATIVE FOR THE PATIENT WAS PURSUING LEGAL ACTION AND HAD SUBMITTED PAPERWORK AS PART OF THE LITIGATION PROCESS. UPON RECEIPT, VISUAL INSPECTION IDENTIFIED BODILY FLUID CONTAMINATION IN THE LEAD BARRELS AND A DENT WAS FOUND ON THE FRONT OF THE TITANIUM CASING. ALL OF THE SEAL PLUGS WERE INTACT AND ALL OF THE SET SCREWS OPERATED NORMALLY. THE INTERROGATED BATTERY STATUS INDICATOR WAS AT BEGINNING-OF-LIFE (BOL) ASSOCIATED WITH A MONITORING VOLTAGE OF 2.931 VOLTS. BECAUSE OF THE ACTIVE LEGAL STATUS, NO FURTHER LABORATORY TESTING WILL BE PERFORMED UNTIL THE LEGAL HOLD HAS BEEN LIFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18290 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N118

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR 4525| 0184| N118| 4518| 4470| 4592