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• Nerve damage in the case of the cu electrode constricting the nerve
• Skin reactions to the material of the external components of the ActiGait® (Heel
Switch and Antenna Fixture) in permanent contact with the body
• Device extrusion/migration
• In the presence of strong, environmental electromagnetic elds the device may
heat excessively or send out uncontrolled pulses to the nerve
• If the ActiGait® malfunctions and the device does not stimulate, the patient may
stumble
• Intolerable sensory stimulation during use (pain or paresthesia)
• Muscle pain may result from too high stimulation intensity or continuous stimu-
lation
• Pain in the ankle joint or other joints of the aected and non-aected lower limbs
may result from a change in movement pattern or improper programming of the
ActiGait®
• The distance between the Implant and the Antenna of the external device may
exceed 40 mm due to swelling around the Implant after operation, general
oedema, or increase in the subcutaneous adipose layer
• Damage to the external parts of the ActiGait® due to improper cleaning methods
• Inability to produce an acceptable dorsiexion movement due to 1) excessive
spasticity, 2) improper programming of the ActiGait® or 3) movement or incorrect
installation of the cu-electrode
The safety of the ActiGait® has been documented by evaluating reports on Device
Related Adverse Events and measurements of conduction velocity of the common
peroneal nerve (branches for extensor digital muscles, anterior tibial muscle and
peroneal muscles) before and three months after implantation.
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