BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1853607 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14896
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 20, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE FOLLOW UP VISIT, 30 DAYS POST IMPLANT, THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS NOTED TO HAVE REDNESS AROUND THE POCKET WOUND. ANTIBIOTIC THERAPY WAS STARTED FOR 10 DAYS IN CASE OF INFECTION. THE PATIENT WILL BE MONITORED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention