BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2780526 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12859
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT NO KNOWN CONTRAINDICATIONS WITH THIS DEVICE AND AN LVAD AND THEREFORE, THE THERAPY SHOULD HAVE BEEN TURNED BACK ON AFTER THE PROCEDURE. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTED. THREE WEEKS AFTER THIS PROCEDURE AT A FOLLOW UP VISIT, TACHY THERAPY WAS FOUND TO STILL BE PROGRAMMED OFF DUE TO THE SURGERY. TACHY THERAPY WAS TURNED BACK ON. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 62 YR Life Threatening 0184| E110| 4054