Medtronic, medical devices, medical technology, coronary artery disease, heart disease, syncope, pacemakers, ICD's, arrhythmia, cardiac arrest, heart failure, heart attack, cardiomyopathy, defibrillator, automated external defibrillators AEDs, heart valve, aortic aneurysms, vascular, neurological disorders, neurostimulation, shaking, Parkinson's, spinal surgery, spinal disorders, Dystonia, pain management, chronic pain, diabetes, Glucose, insulin, blood sugar, obesity, ENT, gastric, gastrointestinal, digestive problems, bladder control, incontinence, prostate, Benign Prostatic Hyperplasia

Important safety information

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.

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.

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.

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

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.

Pain Management