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| | Important safety information
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CONTRAINDICATION
Do not use shortwave diathermy, microwave diathermy or therapeutic ultrasound
diathermy (all now referred to as diathermy) on patients implanted with
a neurostimulation system. Energy from diathermy can be transferred through
the implanted system and can cause tissue damage at the location of the
implanted electrodes, resulting in severe injury or death.
Diathermy is further prohibited because it can
also damage the neurostimulation system components resulting in loss of
therapy, requiring additional surgery for system explantation and replacement.
Injury or damage can occur during diathermy treatment whether the neurostimulation
system is turned "on" or "off." Advise your patients
to inform all their health care professionals that they should not be
exposed to diathermy treatment.
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Brief Summary
Product technical manual must be reviewed prior to use for detailed disclosure. |
Indications
The Medtronic Mattrix®, Itrel® and Synergy® Neurostimulation
systems are indicated as an aid in the management of chronic, intractable
pain of the trunk or limbs. X-trel and Mattrix Receiver Model 3272 systems
are also indicated for peripheral nerve stimulation. Peripheral nerve stimulators
are used to stimulate electrically a peripheral nerve in patients to relieve
severe intractable pain. |
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Contraindications
Unsuccessful pain relief during trial stimulation of the spinal cord or
peripheral nerve, or inability
of patients to properly operate the system. The X-trel and Mattrix systems
also are contraindicated for patients with an implantable cardiac pacemaker
or cardioverter/defibrillator, or for those patients who will be exposed
to magnetic resonance imaging (MRI).
Also, diathermy (e.g., shortwave diathermy, microwave
diathermy or therapeutic ultrasound diathermy) is contraindicated because
diathermy's energy can be transferred through the implanted system (or
any of the separate implanted components), which can cause tissue damage
and can result in severe injury or death. Diathermy can damage parts of
the neurostimulation system.
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Warnings/Precautions
Safety has not been established for pregnancy or paediatric use. Patients
should not drive or use dangerous equipment during stimulation. Systems
may be affected by or adversely affect cardiac pacemakers, cardioverter/defibrillators,
external defibrillators, MRI, ultrasonic equipment, electrocautery, radiation
therapy, theft detectors, security systems, and aircraft communications
systems |
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Adverse Events
Adverse events may include: undesirable change in stimulation described
by some patients as uncomfortable, jolting or shocking; haematoma, epidural
haemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic
response, hardware malfunction or migration, pain at implant site, loss
of pain relief, chest wall stimulation, and surgical risks. Patient
selection criteria include physiological origin for the pain, appropriate
surgical candidate, detoxification from narcotics,
and availability of long-term post-surgical management.
For a complete list of adverse events, please refer
to the current product technical manual.
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