BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 1874687 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17722
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 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 EXPLANTED DEVICE AND LEAD WERE NOT RETURNED TO BOSTON SCIENTIFIC CRM. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND RIGHT VENTRICULAR DEFIBRILLATION LEAD WERE REPOSITIONED DUE TO MIGRATION ON (B)(6), 2010. (RIGHT ATRIAL LEAD IS A COMPETITOR PRODUCT) THE REVISION PROCEDURE WAS A VERY DIFFICULT PROCEDURE AND THE POCKET WAS OPEN FOR 2.5 HOURS. ON (B)(6) 2010 THE ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION.

    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