BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3905375 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10137
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 7, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMSPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT REMOTE MONITORING OF THIS SYSTEM REVEALED HIGH OUT OF RANGE SHOCK IMPEDANCES. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A FOLLOW UP VISIT WAS PERFORMED. INTERROGATION REVEALED THE SHOCK IMPEDANCE MEASUREMENT TRENDING SHOWED CONSISTENT FLUCTUATIONS IN VALUES. THE BEEPING WAS PROGRAMMED OFF. A DECISION WAS MADE TO FURTHER MONITOR THIS SYSTEM REMOTELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383006 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N107

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR 4087| 0181| 4592| N107