ACUITY™ X4 Quadripolar LV Leads

Indications

This Boston Scientific lead is indicated for use as follows: Intended for chronic, left-ventricular pacing and sensing via the coronary venous system when used in conjunction with a compatible pulse generator. The Boston Scientific ACUITY X4 lead is a steroid-eluting (dexamethasone acetate) IS4 quadripolar lead.

Contraindications

Use of this Boston Scientific lead is contraindicated for the following patients: Patients with a hypersensitivity to amaximum single dose of 0.54 mg dexamethasone acetate.

Warnings

Read the manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. Such damage can result in patient injury or death. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. When using a right ventricular (RV) pace/sense lead in conjunction with this left coronary venous pace/sense lead, it is recommended that a polyurethane- insulated lead be used. Lead fracture, dislodgment, abrasion, or an incomplete connection can cause a periodic or continual loss of pacing or sensing or both. Although pliable, the lead is not designed to tolerate excessive flexing, bending or tension. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. Use caution handling the lead terminal when the Connector tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats and clamps. Do not contact any other portion of the lead terminal, other than the terminal pin, even when the lead cap is in place. When implanting a system which uses both a DF4-LLHH/LLHO and IS4-LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Implant of the system cannot be performed in an MRI site zone III (and higher). Only use the Connector Tool for electrical connections to pacing system analyzers or similar monitors. Take care to obtain appropriate electrode position.. When connecting the lead to the pulse generator, it is very important that proper connetions are made. Unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide. Do not subject a patient with an implanted pulse generator and/or lead to diathermy since diathermy may cause fibrillation, burning of the myocardium, and irreversible damage to the pulse generator because of induced currents.

Precautions

Refer to the lead product labeling for cautions specific to clinical considerations, sterilization and storage, handling, implantation, hospital and medical environments, and follow-up testing. Failure to observe these cautions could result in incorrect lead implantation, lead damage and/or harm to the patient.

Potential Adverse Events

Potential adverse events 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, warnings/precautions and adverse events. Rx only. (Rev. B) 046774 AF

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