BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2153209 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06113
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    February 29, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    DURING A RECENT CLINICAL FOLLOW-UP, HIGH OUT OF RANGE SHOCK IMPEDANCE VALUES WERE AGAIN OBSERVED. THE PHYSICIAN PERFORMED A SYNCHRONOUS SHOCK (1.1 JOULE), WHICH RETURNED A SHOCK IMPEDANCE VALUE OF 94 OHMS. THE PHYSICIAN ELECTED TO NOT PERFORM ANY FURTHER TESTING AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION BY ENGINEERING FROM A SAVE TO DISK OF THE DEVICE NOTED THAT THIS DEVICE HAD TWO FAULTS. ONE WAS A LEAD LEAKAGE FAULT WHICH OCCURRED DURING IMPLANT AND WAS MOSTLY A RESULT OF ELECTRO-CAUTERY, WHILE THE OTHER FAULT WAS A MEMORY ERROR WHICH WAS AUTOMATICALLY DETECTED AND CORRECTED. A NORMAL FOLLOW UP OF THIS PATIENT WAS SUGGESTED BY TECHNICAL SERVICES.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT THE FIELD CLINICAL ENGINEER REQUESTED ANALYSIS BY A TECHNICAL SERVICES REPRESENTATIVE WHEN IT COMES TO PROCEEDING WHEN IT COMES TO HIGH OUT OF RANGE SHOCKING IMPEDANCES OBSERVED. TECHNICAL SERVICES DISCUSSED LEAD TROUBLESHOOTING. THE FELID CLINICAL ENGINEER CONFIRMED THAT CURRENTLY THE SHOCKING IMPEDANCES TREND IS STABLE AND ISOMETRIC TESTING WAS NOT SHOWING ANY ABNORMAL MEASUREMENTS. A SAVE TO DISK WILL BE SENT TO TECHNICAL SERVICES FOR REVIEW.

    Additional Manufacturer Narrative · 1

    SUBSEQUENTLY AT A FOLLOW UP A SYNCHRONIZED 41 JOULE SHOCK WAS PERFORMED TO CHECK THE INTEGRITY OF THE LEAD. THE SHOCKING IMPEDANCES WERE WITHIN NORMAL RANGE, WHILE AFTER THE TEST SENSING WAS LOW. A REVIEW OF THE MOST RECENT DISK ANALYSIS SHOWS A COMMAND SHOCK OF 41 JOULE AND A NORMAL SHOCKING IMPEDANCES. A REVIEW OF ALL ELECTROCARDIOGRAMS SHOWS NO NOISE ON THE VENTRICULAR CHANNEL. TECHNICAL SERVICES DISCUSSED KEEPING A CLOSE FOLLOW UP ON THE RIGHT VENTRICULAR ELECTRICAL PARAMETERS. AT THE TIME THE DEVICE AND LEAD REMAIN IMPLANTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECIEVED INFORMATIONT THAT A RED ALERT WAS TRIGGERED DUE TO HIGH OUT OF RANGE SHOCKING IMPEDANCES ON THIS CARDICA RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). AT THIS TIME NO ADDITIONAL INFORMAITON IS AVAILABLE AND THIS DEVICE REMAINS IMPLANTED. NO 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
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 4480| 4591| P107| 0181