BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2051641 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03370
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. 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 REPORTED THAT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) PROCEDURE WAS PERFORMED. SHOCKS DELIVERED AT 1.1 JOULES AND 41 JOULES EXHIBITED IMPEDANCE MEASUREMENTS WITHIN ACCEPTABLE LIMITS. A DEFIBRILLATION THRESHOLD TEST WAS ALSO SUCCESSFUL.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LOW SHOCK IMPEDANCE MEASUREMENT WAS DETECTED ON THIS DEVICE SYSTEM. THE PATIENT WAS BROUGHT INTO THE CLINIC FOR FURTHER EVALUATION. OUT OF RANGE IMPEDANCE MEASUREMENTS WERE UNABLE TO BE RECREATED. TECHNICAL SERVICES DISCUSSED TESTING RECOMMENDATIONS. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED WITH THIS CLINICAL OBSERVATION.

    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 79 YR MISMATCH| (B)(4)| (B)(4)| (B)(4)| (B)(4)