St. Jude Medical Tendril MRI LPA1200M, Руководство пользователя

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Description
The Tendril MRI ™ lead, Model LPA1200M, is an MR Conditional, bipolar, steroid-eluting, active
fixation implantable lead with Optim ™ insulation. The Tendril MRI lead is designed for long-term
pacing and sensing in either the right atrium or right ventricle. The Tendril MRI lead has two
conductors: one terminating at the tip helix and the other at the ring electrode.
The minimum recommended introducer size is 8 French without a retained guidewire and
10.5 French with a retained guidewire.
Features of the Tendril MRI lead include:
 Soft tip header — reduces lead tip pressure
 Optim insulation — a silicone-polyurethane copolymer
 Marker ring — to facilitate optimal lead positioning
 Active fixation — features a rotating, extendable/retractable helix for secure anchoring
 Steroid elution — the target dose of dexamethasone sodium phosphate (DSP) in the
monolithic controlled release device (MCRD) is 460 micrograms
For information on the specifications of any of these lead models, refer to Technical Specifications
(page 31).
Indications and Usage
The Tendril MRI
™
lead is a 7.9 French, transvenous, steroid eluting, bipolar, IS-1 compliant,
active fixation lead 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 MRI lead
may be indicated for patients where permanent fixation of a passive lead is suspected to be
unstable.
In atrial applications, the use of screw-in leads such as Tendril MRI lead may be indicated in the
presence of an abnormal, surgically altered or excised atrial appendage.
Contraindications
The Tendril MRI ™ 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.
MR Conditional System
The St. Jude Medical ™ MR Conditional lead is part of the St. Jude Medical MR Conditional
system.
Patients with an implanted St. Jude Medical MR Conditional system can have an MRI scan if the
conditions for use, as described in the MRI-Ready Systems Manual, are met.
Warnings and Precautions

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 device, 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