BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1944700 · Received January 3, 2011

    Report

    Report Number
    2124215-2010-20013
    Event Type
    Injury
    Date Received
    January 3, 2011
    Date of Event
    October 7, 2010
    Report Date
    October 7, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Removal / Correction Number
    Z-0949-05 THRU Z-0953-05
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ADVERSE EVENTS REPORTED FOLLOWING THIS INVASIVE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS PRESENTED TO THE ELECTROPHYSIOLOGY (EP) LABORATORY FOR A SCHEDULED DEVICE REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). WHEN THE POCKET SITE WAS OPENED, THE PHYSICIAN FOUND THAT THE POCKET WAS INFECTED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WILL BE SCHEDULED A SYSTEM EXTRACTION IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H177

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L H177| 497-23| 432-04| 1861| 4549| 101-09