Instructions For The Physician - Boston Scientific Precision Manuel

Precision™ Spinal Cord Stimulator System Clinician Manual
of reactive tissue around the lead in the
epidural space can result in delayed
onset of spinal cord compression and
neurological/sensory deficit, including
paralysis. Time to onset is variable, possibly
ranging from weeks to years after implant.
• Skin erosion at the IPG site can occur over
time.
• Possible surgical procedural risks are:
temporary pain at the implant site, infection,
cerebrospinal fluid (CSF) leakage and,
although rare, epidural hemorrhage,
seroma, hematoma and paralysis.
• External sources of electromagnetic
interference may cause the device to
malfunction and affect stimulation.
• Exposure to MRI can result in heating of
tissue, image artifacts, induced voltages
in the neurostimulator and/or leads, lead
dislodgement.
• Undesirable stimulation may occur over
time due to cellular changes in tissue
around the electrodes, changes in electrode
position, loose electrical connections and/or
lead failure.
• The patient may experience painful
electrical stimulation of the chest wall as a
result of stimulation of certain nerve roots
several weeks after surgery.
• Over time, the Stimulator may move from its
original position.
• Weakness, clumsiness, numbness or pain
below the level of implantation.
• Persistent pain at the IPG or lead site.
In any event, instruct the patient to contact their
physician to inform him/her.
Clinician Manual
90607862-22 Rev A 14 of 303

Instructions for the Physician

Implanted Stimulation Devices. If such
implanted devices are indicated for the patient,
careful screening is required to determine if safe
results can be achieved before permanently
implementing concurrent electrical therapies.
Postural Changes. Depending on the activity
level of the patient, postural changes may
affect stimulation intensity. Instruct patients to
keep the Remote Control on hand at all times,
and ensure that they understand how to adjust
stimulation levels.
Medical Devices/Therapies. If the patient is
required to undergo lithotripsy, electrocautery,
external defibrillation, radiation therapy,
ultrasonic scanning, or high-output ultrasound:
• Turn off stimulation at least five minutes
before the procedure or application.
• All equipment, including ground plates and
paddles, must be used as far away from the
IPG as possible.
• Bipolar electrocautery is recommended. Do
not use monopolar electrocautery.
• Every effort should be taken to keep fields,
including current, radiation, or high-output
ultrasonic beams, away from the IPG.
• Equipment should be set to the lowest
energy setting clinically indicated.
• Instruct patients to confirm IPG functionality
following treatment by turning on the IPG
and gradually increasing stimulation to the
desired level.