Product Info

10001045 REV B 22
7 ADVERSE EVENTS
Adverse events, or side effects, are risks associated with the use of the Senza
®
Bluetooth
®
Trial System or any
other SCS system. There are adverse events associated with the lead implant procedure, with stimulation, and
with the device itself. Patients should contact their doctor if they experience any adverse events associated with
their device.
7.1 Possible Adverse Events Associated with the Implant Procedure and Additional Medical Risks
• Risks associated with anesthesia, including cardiac arrest
• Surgical complications, such as infection, cellulitis, abscess, fever, sepsis, bleeding
• Cerebrospinal fluid leak
• Intracranial hypotension
• Hematoma, seroma or thrombosis
• Epidural hemorrhage
• Impaired or inadequate wound healing, wound dehiscence
• Temporary or persistent tenderness or pain at implant site
• Lead migration leading to ineffective pain control or other undesirable changes in stimulation
• Suboptimal lead placement or migration requiring revision or explant
• Spinal cord compression; nerve, nerve root, or spinal cord injury
• Paralysis
• Death
7.2 Possible Adverse Events Associated with Stimulation
• Loss of pain relief, loss of paresthesia, or unpleasant paresthesia
• Jolting or shocking sensation associated with changes in posture or sudden movements
• Increased pain
• Undesirable stimulation due to changes over time in tissue around electrodes, changes in electrode
position, loose electrical connections, or lead failure
• Uncomfortable stimulation of tissue around the leads including skin and muscle
• Other undesirable sensation such as tingling or prickling
• Weakness, clumsiness or numbness
7.3 Possible Adverse Events Associated with Implanted Device Components
• Tissue reaction or allergy to implanted materials
• Persistent pain at lead implant site
• Failure of device components including lead breakage or movement (migration), hardware malfunctions,
loose connections, electrical shorts or open circuits, and lead insulation breaches