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 for Use: The Durata® Models 7120, 7120Q, 7121, 7121Q, 7122, 7122Q, 7170, 7170Q, 7171, 7171Q and 7172Q transvenous leads are indicated for use with compatible pulse generators (refer to the applicable defibrillator manual for system indications). They provide pacing and sensing and deliver cardioversion/defibrillation therapy to the heart. A transvenous lead system may offer the patient the benefit of avoiding a thoracotomy for lead implantation. If the initial lead configuration is not effective, repositioning of the lead or other lead configurations should be attempted. In some patients, a nonthoracotomy lead configuration may not provide reliable conversion of arrhythmias, and the use of subcutaneous or epicardial patch defibrillation leads should be considered.
Contraindications: Contraindications for use of the Durata leads with an implantable pulse generator include ventricular tachyarrhythmias resulting from transient or reversible factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction. Transvenous lead systems are contraindicated for patients with tricuspid valvular disease or a mechanical heart valve. Durata leads are contraindicated for patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate is contraindicated. The Durata 7120, 7120Q, 7121, 7121Q, 7122, 7122Q, 7170, 7170Q, 7171, 7171Q and 7172Q leads are contraindicated for extra firm (red color knob) stylets. The lead is not designed, sold, or intended for use other than as indicated.
1. St. Jude Medical DF1 lead connectors conform to the international connector standard ISO 11318/Amd.
2. St. Jude Medical IS-1 lead connectors conform to the international connector standard ISO 5841.
3. St. Jude Medical DF4 lead connectors conform to the international connector standard ISO 27186: 2010 (E).
Potential Complications: Possible complications of the use of transvenous lead systems include, but are not limited to, supraventricular or ventricular arrhythmias, conduction disturbances, cardiac perforation, cardiac tamponade, loss of contractility, air embolism, heart wall rupture, myocarditis, post-operative heart failure, chronic mechanical stimulation of the heart, tricuspid valve dysfunction, lead fracture necessitating surgical removal, pneumothorax, hemothorax, infection, tissue necrosis and erosion of the skin. Specific events and effects are summarised below:
WARNING: Implanted cardiac leads are subjected to a hostile environment within the body due to constant, complex flexural and torsional forces, interactions with leads and/or the pulse generator, or other forces associated with cardiac contractions and patient physical activity, posture and anatomical influences Cardiac leads’ functional lifetimes can be affected by these and other factors.
Refer to the defibrillator manual for additional complications and precautions specific to the pulse generator.