BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3040721 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-03765
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EFFORTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THIS SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE THERAPIES THAT WERE DELIVERED WERE DEEMED TO BE APPROPRIATE. NO PROGRAMMING CHANGES WERE PERFORMED DURING THE PATIENT'S HOSPITAL VISIT. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD BEEN FLOWN TO A HOSPITAL FOR TREATMENT. THE PATIENT HAD RECEIVED ANTI-TACHYCARDIA PACING (ATP) THERAPY AND SIXTEEN SHOCKS WHICH DID NOT CONVERT THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143216 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| R 4194| N119| 1688TC| 0158