ACUITY X4™
– Manual 359160-004

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

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 a maximum 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 connections 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

Based on the literature and on pulse generator and/or lead implant experience, the following alphabetical list includes the possible adverse events associated with implantation of products described in this literature:

Acceleration of arrhythmias; Adverse reaction to procedure (e.g., bradycardia, general, respiratory, hypotension); Air embolism; Allergic reaction; Arterial damage with subsequent stenosis; Bleeding; Bradycardia; Breakage/failure of the implant instruments; Cardiac perforation; Cardiac tamponade; Chronic nerve damage; Component failure; Conductor coil fracture; Death; Electrolyte imbalance/dehydration; Elevated thresholds; Erosion; Excessive fibrotic tissue growth; Extracardiac stimulation (muscle/nerve stimulation); Fluid accumulation; Foreign body rejection phenomena; Formation of hematomas or seromas; Heart block; Hemorrhage; Hemothorax; Inability to pace; Inappropriate therapy (e.g., shocks and antitachycardia pacing [ATP] where applicable, pacing); Incisional pain; Incomplete lead connection with pulse generator; Infection including endocarditis; Lead dislodgment; Lead fracture; Lead insulation breakage or abrasion; Lead tip deformation and/or breakage; Malignancy or skin burn due to fluoroscopic radiation; Myocardial trauma (e.g., irritability, injury, tissue damage); Myopotential sensing; Oversensing/undersensing; Pericardial rub, effusion; Pneumothorax; Pulse generator and/or lead migration; Shunting current or insulating myocardium during defibrillation with internal or external paddles; Syncope; Tachyarrhythmias, which include acceleration of arrhythmias and early, recurrent atrial fibrillation; Thrombosis/thromboemboli; Valve damage; Vasovagal response; Venous occlusion; Venous trauma (e.g., perforation, dissection, erosion).

For a list of potential adverse events associated with MRI scanning, refer to the ImageReady MR Conditional Pacing System or Defibrillation System MRI Technical Guide

Additionally, potential adverse events associated with implantation of a coronary venous lead system include: Allergic reaction to contrast media; Prolonged exposure to fluoroscopic radiation; Renal failure from contrast media used to visualize coronary veins.

92436276 (Rev. A)