UltiPace™ Pacing Lead

Important Safety Information

UltiPace™ Pacing Leads

Rx Only

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: UltiPace™ leads are indicated for use in combination with a compatible pacemakers, implantable cardioverter defibrillator (ICDs) or cardiac resynchronization therapy (CRT-P/CRT-D) to provide sensing and pacing for the management of chronic symptomatic bradycardia and various atrioventricular conduction abnormalities in patients who experience syncope, presyncope, fatigue, disorientation due to arrhythmia/ bradycardia, or any combination of these symptoms. The UltiPace leads are implanted transvenously in either the right atrium, the right ventricle or the left bundle branch area.

Contraindications: UltiPace™ leads are contraindicated: in the presence of tricuspid atresia (if the lead is to be positioned in the right ventricle or left bundle branch area), for patients with mechanical tricuspid valves (if the lead is to be positioned in the right ventricle or left bundle branch area), in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.

Adverse Effects: Potential adverse effects and their categories associated with the use of UltiPace™ leads are the same as with the use of other active fixation leads and include: 

• Arrhythmia (Accelerated arrhythmia, Induced atrial ectopy or arrhythmias, Induced atrioventricular or bundle branch block, Induced ventricular ectopy or asystole, Myocardial irritability)
• Cardiac perforation (Cardiac tamponade, Pericardial Effusion, Pericarditis, Septal perforation)
• Death
• Embolism (Air embolus, Dislodgement of intracardiac thrombus, intravascular foreign body)
• Extra-cardiac stimulation
• Heart failure (Right ventricular decompensation, Tricuspid valve dysfunction/Tricuspid valve regurgitation/insufficiency)
• Hypersensitivity (Hypersensitivity, including local tissue reaction or allergic reaction)
• Infection (Endocarditis)
• Lead revision or reprogramming resulting from, but not limited to, loss of pacing and/ or sensing (Electrical malfunction of the lead, Lead dislodgement, Lead dysfunction (sensing/threshold Issue), Mechanical malfunction of the lead)
• Lung perforation (Hemothorax, Pneumothorax)
• Pulmonary edema
• Prolonged exposure to fluoroscopic radiation
• Respiratory compromise
• Tricuspid value perforation
• Vascular injury (Arterial perforation, Arteriovenous fistula, Coronary sinus or coronary vein perforation/dissection, Hemorrhage/ Hematoma at device site, Venous perforation, Septal hematoma)
• Vascular thrombosis/ stenosis/ occlusion

The physician should discuss the patient's potential adverse events with them.

Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.