Product Info
Safety Information
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
92366224-01 13 of 29
• Pain, headache or discomfort
• Pneumonia from difculty with swallowing or from inhaling uid
• Psychiatric disturbances such as anxiety, depression, lessened interest or emotion,
hypersexuality, aggression, mania or hypomania, psychosis, emotional sensitivity, sleep
problems, suicide, or suicidal thoughts or attempts
• Seizures
• Sensory changes
• Speech or language problems
• Swallowing difculty
• Systemic effects such as rapid heart beat, sweating, fever, dizziness, changes in
kidney function, difculty passing urine, sexual effects, nausea, difculty having bowel
movements, bloating
• Weakness, muscle spasms, shaking, restlessness, or problems with movement
• Undesirable sensations (e.g., tingling)
• Visual problems, eyelid or eye movement difculties or other eye‑related symptoms
• Weight changes
Device‑Related Risks
• Allergic or immune system response to implanted materials
• Failure or malfunction of any part of the device, including but not limited to: Battery
leakage, battery failure, Lead or Extension breakage, hardware malfunctions, loose
connections, electrical shorts or open circuits, and Lead insulation breaches, whether or
not these problems require device removal and/or replacement
• Implant site complications such as pain, poor healing, redness, warmth, swelling or
wound reopening
• Implanted device components (Stimulator, Lead, or Extension) may move from original
implanted location or wear through the skin, which may lead to the need for additional
surgery
• Infection
• Interference from external electromagnetic sources
• Loss of adequate stimulation
• Pain, headache or discomfort
• Skin irritation or burns at the Stimulator site
• Stiffness in muscles or joints
• Worsening of disease symptoms, potentially caused by loss of stimulation, medication
changes, surgery, or illness. In rare cases worsening can become a life‑threatening crisis
associated with varied symptoms such as mental status changes, fever, and muscle
rigidity
• Swelling, including uid collecting around the device