SPINAL CORD STIMULATION
The Medtronic SCS neurostimulation system is indicated for SCS as an aid in the management of the following conditions:
▪ chronic, intractable pain of the trunk and/or limbs.
▪ stable intractable Angina Pectoris in patients who are not candidates for revascularisation.*
▪ stable intractable Peripheral Vascular Disease of Fontaine Stage II or higher in patients who are not candidates for revascularisation.*
INTENDED USE
The Medtronic SCS system delivers electrical stimulation to selected areas of the spinal cord to treat indicated patients. The Medtronic SCS system consists of a multi programmable neurostimulator, one or more leads, and one or more optional extensions to connect the leads to the neurostimulator. An external clinician programmer is used to noninvasively adjust patient stimulation parameters. Patients may also make stimulation adjustments, based on their pain needs and clinician-prescribed programming options, via an external patient programmer.
Additional Warning
In addition to the warnings summarised in the Information for Prescribers (IFP) booklet, the implantation of an SCS system for angina includes the following warning:
Intractable angina pectoris - Patients treated for intractable angina pectoris should be educated on the signs and symptoms of myocardial infarction and should seek medical attention immediately if signs and symptoms develop.
Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualisation of treatment, patient selection, use in specific populations, resterilisation, and component disposal.
ADDITIONAL PRECAUTIONS FOR SURGICAL LEADS
In addition to the precautions summarised in the Information for Prescribers (IFP) booklet, the implantation of a peripheral nerve stimulation system also includes the following precautions:
Peripheral nerve handling - Be extremely careful to avoid excess manipulation and irritation of the peripheral nerve, if the nerve is irritated, the patient may experience pain, dysesthesia, or uncomfortable stimulation.
Peripheral nerve location - Avoid implanting the paddle and the lead body in an area of repetitive movement (eg, over a joint). Repetitive movement can break a lead wire, resulting in intermittent or loss of stimulation.
Additional adverse event
In addition to the adverse events summarised in the Information for Prescribers (IFP) booklet, the implantation of a peripheral nerve stimulation system also includes the following risk:
Nerve damage or degeneration
Refer to the appropriate information for prescribers booklet for contraindications, warnings, precautions, adverse events summary, individualisation of treatment, patient selection, use in specific populations, resterilisation, and component disposal.
See the device manual for detailed information regarding the instructions for use, the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events If using an MRI SureScan® device, see the MRI SureScan® technical manual before performing an MRI. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu.
References
*
Physicians using SCS to treat these conditions are encouraged to share their results in scientific exchange or with Medtronic.