BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1946187 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-21186
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    September 12, 2010
    Report Date
    October 14, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE'S SENSITIVITY WAS CHANGED AND THE PATIENT WILL BE MONITORED. AS OF TODAY THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE OVERSENSED NOISE RESULTING IN PACING INHIBITION FOR APPROXIMATELY TWO SECONDS. THE PATIENT WAS NOT SYMPTOMATIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR MISMATCH| 0185| 4285| 4269| 1270| (B)(4)| N119| 1232