BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 1953619 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24561
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    October 15, 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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS THAT WAS ABLE TO BE REPRODUCED WHEN THE PATIENT RAISED THEIR ARMS. THE PHYSICIAN IS STILL CONTEMPLATING IF HE WILL PERFORM A LEAD REVISION PROCEDURE. IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) ELECTED TO TURN OFF DAILY MEASUREMENTS FOR THE HIGH SHOCK IMPEDANCE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED THAT THE LEAD HAD LIKELY PERFORATED THE RIGHT VENTRICLE. A REVISION PROCEDURE WAS PERFORMED WHERE A PORTION OF THE EXISTING RV LEAD WAS SURGICALLY ABANDONED DUE TO THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS AND SUSPECTED PERFORATION. SINCE RV THRESHOLD AND SENSING MEASUREMENTS HAVE BEEN STABLE AND THE LEAD WAS IMPLANTED APPROXIMATELY EIGHT YEARS EARLIER, IT IS UNKNOWN WHEN THE PERFORATION OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS THAT WAS ABLE TO BE REPRODUCED WHEN THE PATIENT RAISED THEIR ARMS. THE PHYSICIAN IS STILL CONTEMPLATING IF HE WILL PERFORM A LEAD REVISION PROCEDURE. 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 N119

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR H215| 5076| 0185| H175| H170| 4046| 4513| N119| 4470