BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2053362 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04548
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 24, 2011
    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

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS SURGICALLY ABANDONED AND THE ADAPTER WAS EXPLANTED DUE TO NOISE, OVERSENSING AND LOSS OF CAPTURE. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT THEY WERE UNABLE TO RECREATE THE NOISE WHILE THE PATIENT WAS ON THE TABLE SO THEY WERE UNABLE TO RULE OUT AN ISSUE WITH THE ADAPTER, HOWEVER A LEAD FRACTURE WAS SUSPECTED. A NEW LEAD AND ADAPTER WERE IMPLANTED WITH THE SAME DEVICE. NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE LEAD REVISION PROCEDURE WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS, NO NOISE WAS OBSERVED ON THE ELECTROGRAM. THE CLINIC WAS UNABLE TO REPRODUCE THE OUT OF RANGE IMPEDANCE MEASUREMENTS WITH ISOMETRICS, ARM MOVEMENTS OR POCKET MANIPULATION. IT WAS NOTED THAT THE LEAD IMPEDANCE IS TYPICALLY AROUND 600 OHMS. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT SHE WAS ABLE TO REPRODUCE THE HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS AND LV LOSS OF CAPTURE WAS OBSERVED IN ALL CONFIGURATIONS. A LEAD REVISION PROCEDURE WILL BE SCHEDULED IN THE FUTURE. NO ADVERSE PATIENT EFFECTS WERE 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 81 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)| (B)(4)