CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The Tendril® SDX lead is designed for permanent sensing and pacing in either the atrium or the ventricle, in combination with a compatible pulse generator. An active lead, such as the Tendril SDX, may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead, such as the Tendril SDX, may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.
Contraindications: The Tendril® SDX lead is contraindicated: In the presence of tricuspid atresia, for patients with mechanical tricuspid valves, in patients who are expected to be hypersensitive to a single dose of one milligram of dexamethasone sodium phosphate.
Potential Adverse Events: Potential complications associated with the use of Tendril® ST leads are the same as with the use of other active fixation leads and include: cardiac tamponade, diaphragmatic stimulation, embolism, excessive bleeding, induced ventricular ectopy, infection, loss of pacing and/or sensing due to dislodgment or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis. Complications reported with direct subclavian venipuncture include pneumothorax, hemothorax, laceration of the subclavian artery, arteriovenous fistula, neural damage, thoracic duct injury, cannulation of other vessels, massive hemorrhage and, rarely, death.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.