BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2070219 · Received April 27, 2011

    Report

    Report Number
    2124215-2011-07287
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE REPORTED CLINICAL OBSERVATIONS WITH THE CALLER. NORMAL IMPEDANCE AND SENSING MEASUREMENTS WERE CONFIRMED. THE CONSULTANT INFORMED THE CALLER THAT THE DEVICE PERFORMS DAILY MEASUREMENTS EVERY TWENTY ONE HOURS BUT REPORTS EVERY TWENTY FOUR HOURS. THERE CAN BE SOME DAYS WHERE TWO DAILY MEASUREMENTS ARE DONE ON A SINGLE DAY. THE FIRST READING IS OOR BUT THE SECOND IS FINE. THE MESSAGE TO CHECK THE LEAD IS GENERATED WITH THE FIRST MEASUREMENT BUT THE SECOND READING IS REPORTED IN THE DEVICE. THE CONSULTANT RECOMMENDED TRYING TO REPRODUCE NOISE WITH ISOMETRICS. THE CALLER WILL PERFORM ISOMETRICS AND CALL BACK IF NEEDED. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT OUT OF RANGE (ORR) ATRIAL IMPEDANCE MEASUREMENTS WERE REPORTED WITH THIS COMPETITIVE LEAD.

    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 73 YR 4271| 0144| T125| 1851| 4076| E110