BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1853608 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-14962
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    July 17, 2010
    Report Date
    July 19, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT A RED ALERT WAS ISSUED FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INDICATING HIGH SHOCK IMPEDANCE >125 OHMS. IMPEDANCE WAS 70-75 OHMS AT IMPLANT AND HAS VARIED SINCE. THE DEVICE WAS PROGRAMMED DISTAL COIL TO CAN. TECHNICAL SERVICES (TS) DISCUSSED DELIVERING A COMMANDED 1.1 JOULE (J) SHOCK AND A MAXIMUM ENERGY SHOCK TO TEST THE INTEGRITY OF THE SYSTEM. NO ADVERSE PATIENT EFFECTS HAVE BEEN 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 30 YR (B)(4)| (B)(4)| (B)(4)