BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 1771530 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12755
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 4, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE AND RECORDS INDICATE THAT THIS DEVICE REMAINS IN SERVICE. IF ADDITIONAL INFORMAITON BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT APPROXIMATELY THREE MONTHS POST IMPLANT OF THIS DEVICE, THIS PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A DEEP VEIN THROMBIS (DVT) IN HIS LEFT INTERNAL JUGULAR VEIN. SYMPTOMS INCLUDED SWELLING TO HIS BECK AND LEFT ARM ONE DAY AFTER DOING LIGHT YARD WORK. THE PATIENT WAS TREATED WITH LOVENOX AND COUMADIN. WHEN INR REACHED THERAPEUTIC RANGE THE LOVENOX WAS DISCONTINUED AND PATIENT CONTINUED ON COUMADIN. THE SUBJECT WAS DISCHARGED WITH NO FURTHER ISSUE. THE PATIENT'S PHYSICIAN REPORTED THAT THIS EVENT COULD POSSIBLY BE RELATED TO THE DEVICE IMPLANT PROCEDURE.

    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 79 YR Hospitalization| L N119| 4591| 4554| 4135| 0157