Tendril

Indications, Safety & Warnings

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: The Tendril STS™ Model 2088TC and Tendril MRI™ Model LPA1200M leads are designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active leads such as the Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of the screw-in leads such as Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.

Contraindications: The Tendril STS Model 2088TC and Tendril MRI Model LPA1200M leads are 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.

Adverse Events: Potential complications associated with the use of Tendril STS Model 2088TC and Tendril MRI Model LPA1200M 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 dislodgement or mechanical malfunction of the pacing lead, phrenic nerve stimulation, thrombosis.

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