BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2041824 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01271
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 16, 2011
    Report Date
    January 21, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE DAYS LATER, THE SYSTEM WAS EXPLANTED. THIS DEVICE IS CURRENTLY BEING USED AS A TEMPORARY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) OUTSIDE THE PATIENT'S BODY, THROUGH JUGULAR ACCESS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE SYSTEM REMAINS IN SERVICE AT THIS TIME. 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 THIS PATIENT HAS AN INFECTED POCKET. THE PATIENT IS DEPENDENT SO THE SALES REPRESENTATIVE WAS INQUIRING IF THEY COULD CLEAN UP THE DEVICE CASING AND USE IT EXTERNALLY UNTIL THE INFECTION CLEARS. TECHNICAL SERVICES DISCUSSED THIS IS OFF LABLE AND NOT RECOMMENDED. TECHNICAL SERVICES RECOMMENDED CONSULTING LITERATURE ON THIS SUBJECT AND REFERRED THE CALLER TO THE HOSPITAL PATHOLOGY LAB TO SEE IF THEY HAVE STANDARD PROCEDURES FOR CLEANING DEVICES.

    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 73 YR Hospitalization| L| R 0184| 4135| N119| MISMATCH