BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1860545 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-15067
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    May 28, 2010
    Report Date
    July 22, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 THERE WERE DIFFICULTIES EXPERIENCED DURING THE IMPLANT PROCEDURE WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PHYSICIAN HAD A DIFFICULT TIME SECURING THE RIGHT VENTRICULAR (RV) TERMINAL PIN INTO THE HEADER. THE SETSCREWS WERE TIGHTENED AND PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS. THE SETSCREWS WERE RETRACTED AND WITH ADDITIONAL FORCE THE TERMINAL PIN WAS FULLY INSERTED INTO THE HEADER. THE SETSCREWS WERE RETIGHTENED AND PACING IMPEDANCES RETURNED TO NORMAL RANGE. TO DATE, THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1