BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2153617 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06753
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 8, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT SERVICES CONSULTANT ADVISED THE PATIENT TO CONTACT HIS PHYSICIAN IF HE HAS ANY CONCERNS REGARDING HIS INCISION, HEALING OR DEVICE SETTINGS. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A DEVICE REPLACEMENT YESTERDAY. FOLLOWING THE PROCEDURE, THE PATIENT STATED HE BEGAN BLEEDING PROFUSELY AND A SECOND SURGERY WAS REQUIRED. THE PATIENT REPORTED THAT THE PHYSICIAN HAD LEFT SOMETHING OPEN AND IT HAD TO BE CLOSED BACK OFF. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY.

    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 75 YR H217| N119| 0184| MISMATCH| 4473| (B)(4)