St. Jude Medical 3046, Руководство для клиницистов

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System testing.
The operation of the system should always be tested after implantation and
before the patient leaves the surgery suite to ensure correct operation.
Component disposal. Return all explanted components to St. Jude Medical for safe disposal.
Home and Occupational Environments
Lead movement. Patients should be instructed to avoid bending, twisting, stretching, or lifting
objects over five pounds during the trial period. Extension of the upper torso or neck may cause
lead movement and alter the stimulation field (especially with leads in the cervical area), resulting
in ineffective or overstimulation.
Adverse Effects
The use of a neurostimulation system involves risk. In addition to those risks commonly associated
with surgery, the following risks are also associated with use of a neurostimulation system:
 Undesirable changes in stimulation, which may be related to cellular changes in tissue
around the electrodes, changes in electrode position, loose electrical connections, or lead
failure
 Stimulation in unwanted places (such as radicular stimulation of the chest wall)
 Lead migration or local skin erosion
 Implant migration
 Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from
placement of a lead in the epidural space
 Cerebrospinal fluid (CSF) leakage
 Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
 Persistent pain at the electrode site or IPG site
 Seroma (mass or swelling) at the implant site
 Allergic or rejection response to implant materials
Product Description
St. Jude Medical™ leads are designed for spinal cord stimulation (SCS) to aid in the treatment of
chronic, intractable pain. SCS is a method of pain control that uses low-intensity electrical
impulses to stimulate nerve fibers within the spinal cord, often inhibiting chronic pain messages
from reaching the brain. Percutaneous leads are designed for introduction into the epidural space
using a special needle. The lead assembly consists of 4 or 8 cylindrical electrodes spaced at
precise intervals. Percutaneous leads are supplied with a stylet to aid in positioning.
Package Contents
The percutaneous trial lead kits contain the following:
Guide wire. Used to establish an appropriate pathway for the lead in the epidural space. The
guide wire is 50 cm (20 in) in length.
Lead anchor. Made of silicone and used to secure the lead to connective tissue for stability.
Epidural needle. Special 14-gauge needle designed for insertion of the percutaneous leads into
the epidural space.
Lead stylet. Inserted in the lead body to assist in steering and positioning.
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