BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3223559 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10061
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    March 1, 2013
    Report Date
    October 28, 2013
    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

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO INFECTION. THIS DEVICE IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET WAS SWOLLEN.THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED AS NO FEVER AND NO PAIN WAS MANIFESTED. THE DEVICE REMAINS IN SERVICE.ADDITIONAL INFORMATION RECEIVED THAT THIS THERE WAS POSSIBLE INFECTION OWEVER AT THE MOMENT NO INTERVENTION WAS DONE FOR THE PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321989 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4096| P107| 4555| 0175