BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1952847 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-24347
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 9, 2010
    Report Date
    January 24, 2011
    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

    ANOTHER FOLLOW-UP APPOINTMENT WAS SCHEDULED TO FURTHER EVALUATE THE SYSTEM. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A REVISION PROCEDURE WAS PERFORMED TO VERIFY PROPER CONNECTIONS. DURING THE REVISION, OUT OF RANGE IMPEDANCES WERE MEASURED ON THE LEAD PROXIMAL SHOCKING COIL. NO CONNECTION ISSUES WERE NOTED. THE DEVICE SHOCKING VECTOR WAS REPROGRAMMED TO SINGLE COIL, USING ONLY THE DISTAL COIL. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE HAD RECORDED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. DURING A FOLLOW-UP APPOINTMENT, NO NOISE COULD BE PRODUCED WITH PATIENT MANEUVERS, AND SHOCK IMPEDANCE MEASUREMENTS WERE IN THE NORMAL RANGE. 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 P106

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention