BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3040696 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00425
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM ENDURED AN INFECTION. A REVISION PROCEDURE WAS PERFORMED AND A FULL SYSTEM EXTRACTION WAS PERFORMED. A TEMPORARY PACING LEAD WAS IMPLANTED AND THE CHRONIC DEVICE WAS TO BE TAPED EXTERNALLY TO THE PATIENT'S NECK. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. AN IMPLANT PROCEDURE WAS TO OCCUR AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142811 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 1488T| H177| MISMATCH| N119| 5076| 0157| 0158| 4537| 4591| 1853