• Leaking of the cerebrospinal fluid (CSF)
• Intracranial hypotension
• Hematoma, seroma, or thrombosis
• Epidural hemorrhage
• Impaired or inadequate wound healing
• Temporary or persistent tenderness or pain at implant site
• Lead movement leading to ineffective pain control or other undesirable
changes in stimulation
• Suboptimal placement or movement of the IPG or lead, requiring another
surgery or explant
• Pressure on the spinal cord, or injury to the spinal cord, nerve, or nerve root
• Paralysis
• Death
Possible Adverse Events Associated with Stimulation
• Loss of pain relief or unpleasant paresthesia, such as tingling or prickling
• Jolting or shocking sensation associated with changes in posture or sudden
movements
• Increased pain
• Changes over time in the cells around the electrodes of the leads, or changes
in the electrode, lead, or its connection, leading to undesirable stimulation
• Uncomfortable stimulation of tissue (such as skin or muscle) around the leads
• Weakness, clumsiness, or numbness
Possible Adverse Events Associated with the Implanted Device Components
• Tissue reaction or allergy to implanted materials
• Persistent pain at the lead or IPG implant site(s)
• Failure of device components or the battery, including lead breakage or
movement (migration), hardware malfunctions, loose connections, electrical
shorts, or open circuits and lead insulation breaches
• Failure or malfunction, resulting in ineffective pain control or other
undesirable changes in stimulation, possibly requiring explant and another
surgery
• Skin erosion or seroma at the lead or IPG site
• Pressure sores
• External sources of electromagnetic interference that could affect stimulation
and/or cause the device to malfunction
• Infection
Patient Manual 11052 Rev A (2015-01-16) 18
To Next Page
Loading...
