BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1873740 · Received October 19, 2010

    Report

    Report Number
    2124215-2010-17199
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    June 29, 2010
    Report Date
    August 28, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THIS PRODUCT REMAINS IN SERVICE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), AN INCREASED RIGHT VENTRICULAR (RV) IMPEDANCE OF GREATER THAN 2000 OHMS, AND NOISE ON THE RV CHANNEL WERE OBSERVED. THE LEAD WAS REINSERTED INTO THE HEADER, AND THE PHYSICIAN NOTED A LOT OF 'BACK PRESSURE'. ON THE FOURTH ATTEMPT, MINERAL OIL WAS USED WITH SUCCESS. TO DATE, THERE HAVE BEEN NO REPORTED ADVERSE PATIENT EFFECTS RELATED TO THIS CLINICAL OBSERVATION.

    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 71 YR (B)(4)| (B)(4)| (B)(4)| (B)(4)