Infections related to the SCS system may require the implanted components to be
explanted. Do not use the charger if the incision is not sufficiently healed. The charger
and the charging belt are not sterile and should not be in contact with the incision.
Cell Phones – The impact of cell phones on the neuromodulation system is unknown
at this time.
IPG Failure
– If your IPG does not provide stimulation even after complete charging of
the IPG or replacement of the batteries in the Patient Remote Control, turn off the IPG
and contact your physician. When frequency of recharging becomes too inconvenient
for you, the IPG may need to be replaced. You should contact your physician if this
occurs.
Device Disposal
– Do not dispose the IPG, Patient Remote Control or Charger in fire.
The battery in these devices can explode in fire. The IPG should be explanted in the
case of cremation. All explanted IPGs should be returned to Nevro Corp. Do not
dispose of electrical components, including batteries, in the unsorted municipal waste
stream. Dispose of electrical components, including batteries, according to local
regulations.
Long-term effectiveness of neurostimulation – The long-term effectiveness of spinal
cord stimulation has been documented. Not all patients realize long-term benefits
from spinal cord stimulation. Stimulation effectiveness at 10 kHz has been established
for one year.
ADVERSE EVENTS
Adverse events, or side effects, are risks associated with the use of this or any other
SCS system. There are adverse events associated with the implant procedure, with
stimulation, and with the device itself. Please contact your physician if you experience
any adverse events associated with the device.
Possible Adverse Events Associated with the Implant Procedure and Additional
Medical Risks
• Risks associated with anesthesia, including cardiac arrest
• Surgical complications, such as infection, fever, or bleeding
Patient Manual 11052 Rev A (2015-01-16) 17
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