BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3211159 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07723
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    September 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN SERVICE THEREFORE WILL NOT BE RETURNED FOR ANALYSIS TO DETERMINE THE ROOT CAUSE OF THIS EVENT. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK IMPEDANCES. THE RIGHT VENTRICULAR (RV) LEAD MODEL AND SERIAL NUMBER ARE UNKNOWN AT THIS TIME WHILE ATTEMPTS HAVE BEEN MADE TO OBTAIN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE HIGH, OUT-OF-RANGE SHOCKING IMPEDANCE ISSUE IS STILL ONGOING. IT WAS REPORTED THAT THE PATIENT HAD A HIGH SHOCKING IMPEDANCE SINCE IMPLANT AT AROUND 110 OHMS. HOWEVER, THE MEASUREMENTS WERE CONSIDERED STABLE AND NO LEAD ISSUES WERE SUSPECTED. ALL OTHER MEASUREMENTS WERE WITHIN NORMAL RANGE AND NO NOISE WAS RECORDED. NO REVISION WAS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310369 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening