BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3210286 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06682
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    November 28, 2009
    Report Date
    April 17, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D REMAINS IMPLANTED AND IN SERVICE. 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 CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PRESENTED WITH A HEMATOMA IN THE POCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED.FOUR YEARS LATER, ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO EXPERIENCED AN INFECTION. A DRAIN WAS PLACED AND THE PATIENT'S MEDICATIONS WERE CHANGED TO RESOLVE THE ISSUE. NO PRODUCTS WERE EXPLANTED AS A RESULT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309205 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening