BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2911904 · Received January 11, 2013

    Report

    Report Number
    2124215-2013-00602
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    March 21, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WAS EXHIBITED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE SHOCKING LEAD IS A COMPEITIOR'S PRODUCT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THIS DEVICE CONTINUES TO EXHIBIT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18107 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4542| 1688TC| 7273| MISMATCH| T125| 6943| 6940| N119