BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 4132371 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14299
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DURING A FOLLOW-UP, THE DEVICE REPORTED SOME OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS UP TO 150 OHMS. ALL OTHER MEASUREMENTS WERE APPROPRIATE AND THERE WERE NO PATIENT SYMPTOMS. THE PATIENT WILL BE FOLLOWED EVERY THREE MONTHS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612959 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P108

    Patients

    Seq Age Sex Outcome Treatment
    1 P108| 0292| 4542| 4480