TELIGEN® Implantable Cardioverter
Defibrillator (ICD)

ICD Systems and Leads from Boston Scientific CRM

ICD Indications and Usage
ICDs are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. ICDs with atrial therapies are also intended to provide atrial antitachycardia pacing and atrial defibrillation treatment in patients who have, or are at risk of developing, atrial tachyarrhythmias. ICD leads provide pacing and rate-sensing and deliver cardioversion and defibrillation shocks for ICD systems.

Contraindications
ICD systems are contraindicated in: Patients whose ventricular tachyarrhythmias may have reversible cause, such as 1) digitalis intoxication, 2) electrolyte imbalance, 3) hypoxia, or 4) sepsis, or whose ventricular tachyarrhythmias have a transient cause, such as 1) acute myocardial infarction, 2) electrocution, or 3) drowning. Patients who have a unipolar pacemaker. ICD leads are contraindicated in: patients with a hypersensitivity to a single dose of approximately 1.0 mg of dexamethasone sodium phosphate and/or 1.0 mg of dexamethasone acetate, or patients with mechanical tricuspid heart valves.

Warnings
Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the ICD system. Such damage can result in patient injury or death. Program the pulse generator Tachy Mode to Off during implant, explant or post-mortem procedures to avoid inadvertent high voltage shocks. Always have sterile external and internal defibrillator protection available during implant. If not terminated in a timely fashion, an induced tachyarrhythmia can result in the patient’s death. Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation (CPR) are present during post-implant device testing should the patient require external rescue. Patients should seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning. Strong magnetic fields may damage the device and cause injury to the patient. Do not subject a patient with an implanted pulse generator to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents. Do not use atrial tracking modes (or an AVT device) in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in VT or VF. (Applies to dual-chamber devices only.) Do not use this pulse generator with another pulse generator. This combination could cause pulse generator interaction resulting in patient injury or lack of therapy delivery. Do not kink leads. Kinking leads may cause additional stress on the leads, possibly resulting in lead fracture. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs. Implanting the pulse generator subpectorally with the serial number facing the ribs may cause repetitive mechanical stress to a specific area of the titanium case, potentially leading to a component failure and device malfunction.

Do not attempt to use the lead system with any device other than a commercially available ICD with which it has been tested and demonstrated safe and effective - potential adverse consequences include, but are not limited to, undersensing of cardiac therapy and failure to deliver necessary therapy. The safety and efficacy of the tip electrode placement above midseptum has not been clinically established (extendable retractable helix leads). Lead fracture, dislodgment, abrasion and/or incomplete connection can cause a periodic or continual loss of rate-sensing, possibly resulting in inappropriate delivery of a PG shock or inadequate delivery of conversion energy. The lead is not designed to tolerate excessive flexing, bending or tension. This could cause structural weakness, conductor discontinuity and/or lead dislodgment. Failure to obtain appropriate electrode position may result in higher defibrillation thresholds or may render lead unable to defibrillate a patient whose tachyarrhythmia(s) might otherwise be convertible by an ICD system. In order to deliver defibrillation therapy, the single-coil lead must be implanted with a separate defibrillation electrode. Boston Scientific CRM recommends using the single-coil lead with a pectorally implanted device that uses the metallic housing as a defibrillation electrode. When connecting the lead to ECD cables and/or the ICD PG it is very important that proper connections are made. Damage to the heart could result if a high-voltage defibrillating pulse were to be delivered through the pace/sense tip electrode. Use of any component of the lead system to assist in the delivery of external-source rescue shocks could cause extensive tissue damage. Do not kink, twist or braid the lead terminals, as doing so could cause lead insulation abrasion damage.

Precautions
For information on precautions, refer to the following sections of the ICD product labeling: clinical considerations, sterilization, storage and handling; implantation and device programming; follow-up testing; explant and disposal; environmental and medical therapy hazards; hospital and medical environments; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.

Refer to the lead product labeling for cautions specific to handling, implanting and testing the lead. Failure to observe these cautions could result in incorrect lead implantation, lead damage, and/or harm to the patient. It has not been determined whether the warnings, precautions or complications usually associated with injectable dexamethasone sodium phosphate/acetate apply to the use of the low concentration, highly localized, controlled-release device. For a listing of potentially adverse effects, refer to the Physician’s Desk Reference. Tricuspid valvular disease may be exacerbated by the presence of a lead. Use medical judgment when deciding to place a lead in a patient with triscuspid valvular disease. The lead and its accessories are intended only for one-time use. Do not reuse.

Potential Adverse Events
Potential adverse events from implantation of the ICD/lead system include, but are not limited to the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, psychologic intolerance to an ICD system - patients susceptible to frequent shocks despite antiarrhythmic medical management/imagined shocking, and component failure. In rare cases severe complications or device failures can occur.

Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
(Rev. I)