ENDOTAK RELIANCE® G Defibrillation Lead

ICD Leads from Boston Scientific CRM

Contraindications
Use of ICD leads are contraindicated in: patients who have a unipolar pacemaker, 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, patients with mechanical tricuspid heart valves.

Warnings
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 converting 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. BSC 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
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, 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)