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A
DVERSE
E
VENT
S
UMMARY
Implantation of a spinal cord stimulation system is similar to any surgical
procedure. Risks include the following:
•
Allergic or immune system response to implanted material
•
Infection
•
Leakage of cerebrospinal fluid
•
Epidural hemorrhage, hematoma, or paralysis
Therapeutic use of the Freedom SCS System incurs the following risks:
•
Undesired change in stimulation, including uncomfortable chest wall
stimulation
•
Stimulator migration, erosion through the skin, or fracture causing a
loss of therapeutic effect
•
Electromagnetic interference causing a change in System performance
•
Loss of therapeutic effect despite a functioning system
Adverse events that could occur with the Freedom SCS System:
•
Stimulator migration, resulting in altered stimulation therapy that may
be uncomfortable
•
Stimulator fracture, resulting in loss of stimulation
•
Infection, resulting in tissue sensitivity, redness and swelling
Adverse effects of stimulation are usually mild and go away when stimulation is
turned off. Contact your clinician immediately if you experience any problems.
Over time there could be changes in the level of pain control. Contact your
clinician if you experience a change in stimulation that you believe is a result of
the Stimulator slipping from the implant site.
