BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2911160 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15918
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 5, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT 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.

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, THIS DEVICE AND RIGHT VENTRICULAR LEAD DISPLAYED A SUDDEN HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. OTHER MEASUREMENTS WERE NORMAL. NO NOISE WAS OBSERVED. A MEMORY DOWNLOAD WAS PERFORMED AND PROVIDED TO TECHNICAL SERVICES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. TECHNICAL SERVICES REVIEWED THE MEMORY DOWNLOAD. THE OUT OF RANGE SHOCK IMPEDANCE WAS INTERMITTENTLY OUT OF RANGE UNTIL RECENTLY. IT WAS RECOMMENDED FURTHER LEAD INTEGRITY TESTING AND/OR A COMMANDED LOW ENERGY SHOCK BE PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: A REVISION PROCEDURE WAS PERFORMED. WHEN THE POCKET WAS OPENED VISUAL OBSERVATION REVEALED THE DISTAL COIL CONNECTOR WAS LOOSE IN THE DEVICE HEADER. AFTER THIS WAS TIGHTENED, NORMAL SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. LEAD INTEGRITY TESTING AND HIGH-ENERGY SHOCK IMPEDANCE REVEALED NORMAL SHOCK IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18577 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P106

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R