BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2163353 · Received July 15, 2011

    Report

    Report Number
    2124215-2011-07192
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A NON-SUSTAINED EPISODE OF ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. THIS EPISODE CONTAINED A TWO TO THREE PAUSES OF APPROXIMATELY TWO SECONDS WHERE IT APPEARED THAT THE DEVICE PACED, BUT IT DID NOT. AS A RESULT, PROGRAMMED CHANGES WERE MADE. 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 N118

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening (B)(4)| (B)(4)| (B)(4)| (B)(4)