Contraindications
Use of LV leads are contraindicated in patients with a hypersensitivity to a nominal dose of 0.45, 0.7 or 1.0 mg dexamethasone acetate drug. Some LV lead models are contraindicated in patients with mechanical tricuspid heart valves, or obstructed or inadequate vasculature for intravenous catheterization.
Warnings
Read the product labeling thoroughly before implanting the lead to avoid damage to the system. Such damage can result in patient injury or death. When using a right ventricular (RV) pace/sense lead in conjunction with an LV lead, it is recommended that a polyurethane-insulated RV lead be used. Failure to observe this warning could result in insulation damage of the RV lead, which can cause a periodic or continual loss of pacing, sensing or both. Lead fracture, dislodgment, abrasion or an incomplete connection can cause a periodic or continual loss of pacing, sensing or both. The use of battery-powered equipment is recommended during lead implantation and testing to protect against fibrillation that might be caused by leakage currents. Line-powered equipment used in the vicinity of the patient must be properly grounded. The lead connector must be insulated from any leakage currents that could arise from line-powered equipment. The lead is not designed to tolerate excessive flexing, bending, tension, or injection pressure. This could cause structural weakness, conductor discontinuity or lead dislodgment. When using a finishing wire accessory kit, use the corresponding finishing wire model for the lead length. If the wrong length finishing wire is used, the finishing wire tip may extend out of the distal end of the lead or not stabilize the lead properly. When placing the lead with a stylet, use only a stylet designed for use with the ACUITY Steerable lead. These stylets are specifically designed to prevent the stylet from extending past the lead tip. Extending the stylet past the lead tip may cause tissue damage. Do not expose a patient to the MRI environment. Strong electromagnetic fields in the MRI environment may interfere with the pulse generator and lead system and cause injury to the patient. Patients with implanted leads should not receive diathermy treatment. Shortwave or microwave diathermy can cause tissue damage and injure the patient. Do not kink, twist, or braid the lead terminal with other leads, as doing so could cause lead insulation abrasion or conductor damage.
Precautions
Refer to the Sterilization and Handling and Lead Evaluation and Implant sections of the 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/dislodgment, or harm to the patient. It has not been determined whether the warnings, precautions, or complications usually associated with injectable dexamethasone 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.
Potential Adverse Events
Potential adverse events from implantation of the 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 (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, warning/precautions and adverse events. Rx only.
Product Type
Lead
Used in Procedures
Cardiac Resynchronization Therapy ImplantationRelated Medical Areas
Cardiac Rhythm ManagementRelated Conditions
Heart Conditions
